Quality Control Supervisor jobs
West Pharma Quality Project Manager United States, Pennsylvania, West Whiteland Township
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In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.
- Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
- Organize and generate detailed quality information reports to show trends and the impact of process improvements.
- Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
- Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
- Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
- Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
- Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
- Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
- Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
- Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
- Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
- Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
- Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
- Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
- Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
- Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
- Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
- Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
- May coordinate the activities of one or more exempt and/or non-exempt employees.
- All other duties as required.
- Bachelor's Degree in Science, Engineering or related field
- 8+ years of relevant work experience required
- 5+ years’ experience in pharmaceutical or medical device environment.
- 2+ years’ experience in a Quality role.
- ASQ CQE certification desirable.
- Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
- Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
- Ability to manage direct report(s), work independently and in a team environment.
- Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
- Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
- Experience with SAP is preferred.
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
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West Pharma Production Supervisor United States, Pennsylvania, Williamsport
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- Supervise shift personnel in the manufacture of customer products consistent with high safety and quality standards.
- Troubleshoot problems arising on the shop floor as it relates to Advanced Manufacturing operations / products, in conjunction with quality standards for throughput and yields with the appropriate engineering support from Engineering functions within the value stream.
- Maintain close observation of orders to keep informed of manufacturing status and, when needed, initiate the necessary steps to conform to schedule / staffing requirements.
- Promote and support site initiatives including safety programs, lean initiatives, training programs, and consistently interpret & apply all policies, practices and procedures among plant team members.
- Recommend and implement measures to motivate team members and to encourage employees to recommend ways to improve process, quality, safety and efficiency.
- Routinely evaluate team member performance and identify training needs. Coach and counsel team members for performance, attendance and behavior. Participate in the resolution of team members relations issues.
- Review and approve work time in the appropriate timekeeping system. Maintain and verify accuracy of the hours each team member has worked.
- Adjust direct labor to support demand and manage available resources to ensure on time production and delivery of customer orders with consistent focus on labor absorption.
- Ensure Safety regulations, OSHA, SOPs, and cGMP are followed.
- Perform routine visual inspection of work areas for unusual occurrences, safety hazards, housekeeping, work space organization and generate work orders where appropriate.
- Network with internal and external customers and other departments as appropriate.
- Actively participate in site wide Safety Committee Team / projects.
- Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
- Participate in special project teams as assigned.
- Education: Bachelor's in a technical discipline to include Business, Operations or Engineering preferred
- 5-8 years of experience in a manufacturing environment, including supervisory experience
- Working knowledge of repetitive process, high tech, manufacturing – mechanical automated systems.
- Must possess strong leadership and managerial skills
- General knowledge of OSHA/EPA/safety regulations, manufacturing and process automation
- Working knowledge of business and shop floor systems to effectively manage operations; prefer SPA and MS Office applications.
- Experience working with ISO9000, FDA and cGMP required.
- Ability to speak effectively before groups and employees in the organization.
- Understanding and experience in use of Lean manufacturing principles to be able to support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
- Health Services\First Aid Certification Upon Hire preferred or
- Health Services\CPR - Cardiac Pulmonary Resuscitation Upon Hire preferred
- Self-motivated and solution-oriented personality.
- Excellent written and verbal skills.
- Good communication, project management, and interpersonal skills.
- Good organizational skills.
- Effective problem-solving skills.
- Must wear safety toe shoes, safety goggles, and hearing protection, as required, in production areas.
- Must follow and comply with Plant’s Dress and Hygiene Code (SOI).
- Must follow and comply with all Company and Plant policies, procedure (SOIs), rules and State and Federal laws
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Boston Scientific Quality Engineer II United States, Minnesota
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About the Role:
In this dynamic production environment, they have the opportunities to develop, establish and maintain quality engineering methodologies, systems, and practices. Serving as representatives of the Quality organization, they will improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
Your Responsibilities Include:
- Partners with Manufacturing Engineering and Production core team members for daily manufacturing line support decisions and practices.
- Collaborates with cross-functional team to evaluate manufacturing results, assist defect detection, primary cause identification, and understanding corrective and preventative actions.
- Identifies and implements effective process control systems to support the development, qualification, validation and verification to meet or exceed internal, external, and regulatory requirements.
- Supports a culture of continuous improvement by advancing improvements to existing processes and controls.
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Broadly engages with production teams across all shifts to develop and support solutions to improve outgoing quality.
- Provide task direction, coaching, and mentorship for technician team members.
- Participate in team decision-making and display team problem-solving/communication skills.
What We’re Looking For:Required Qualifications:
- Bachelor’s degree in engineering, technology, mathematics, or related science
- 2+ years of relevant experience in a regulated industry
- Strong verbal and written communications skills; Good documentation practices
- Works effectively in a Controlled Environment Area (CEA) manufacturing environment
- Self-starter with a proven ability to successfully work with minimal supervision
- Knowledge of basic Quality Management Systems
- Proficient with Microsoft Office tools (Word, Excel, PowerPoint, Outlook)
Preferred Qualifications:
- Medical device experience
- Comfortable with utilizing analytical equipment (including microscopes)
- Strong analytical skills, problem solving, and statistical analysis (Excel, Minitab)
- Experience with the following disciplines: manufacturing/process engineering, post-market complaints, supplier quality, CAPA, risk management
- Experience running/owning nonconforming event risk assessments and investigations
- Proficient using manufacturing control software (various MES, MasterControl, etc.)
- Project management experience
Maximum Salary: $ 132000
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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Boston Scientific Senior Production Supervisor - 2nd Shift United States, Minnesota
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Your Responsibilities will Include:
- Produce high quality products, safely, on time for the customer at the lowest cost
- Facilitate and partner with a cross functional production team of production, quality and manufacturing engineering team members to achieve annual safety, quality, service and cost goals while maintaining a high engagement & high-performance culture
- Identify customer requirements to deliver the right products at the right time
- Be responsive & flexible to customer demands
- Achieve & exceed product cost goals
- Support new product development readiness activities for the line team
- Manufacture products to the highest quality standards and ensure compliance to all Boston Scientific policies and regulations
- Promote safety, quality & compliance among the team while maintaining Good Manufacturing Practices
- Foster teamwork and enable a culture of Operational Excellence throughout the entire cross-functional team
- Ensure effective two-way communication between the production line team and cross-functional support teams
- Manage, motivate, develop, and involve product builders through coaching and performance management
- Embed the company values through demonstration & recognition of individual & team behaviors
- Utilize production area planning tools to ensure all resources are in place to achieve team commitments such as Direct Labor Staffing, Equipment Capacity, Support Team, and Space
- Ensure product builder training is effective & efficient and maintain training versatility across entire team
- Utilize leader standard work to ensure lines are meeting standards and escalate appropriately
- Lead & create team engagement around continuous improvement goals for safety, quality, service, cost and space through the utilization of lean and operational excellence tools and best practices
- Benchmark and share best practices
- Partner with materials management team for build planning and material delivery systems and tools
- Analyze build plan requirements and provide forward looking monthly production commitments
- Anticipate requirements and position resources to meet & exceed the customer needs
- Provide appropriate input into the long-term planning of the production area
Required Qualifications:
- Bachelor’s Degree or equivalent combination of education and experience will be considered in lieu of degree
- Manufacturing or engineering experience
- Solid computer skills required including Microsoft Excel, Word, and PowerPoint
- Demonstrated Lean tools/systems experience
- Able to support and lead a production team working 2nd shift hours (1:30 PM – 9:30 PM), Monday through Friday.
Preferred Qualifications:
- 3+ years of supervisor/management experience
- Experience in a regulated environment
- Medical device industry experience
- Strong written and verbal communication skills with the ability to communicate at all levels of the organization
- Ability to be flexible and agile
- Ability to be a self-starter
Maximum Salary: $ 132000
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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Boston Scientific Senior Design Quality Cybersecurity Engineer United States, Minnesota
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Your responsibilities will include:
- Interpret and apply relevant cybersecurity standards and regulations (e.g., FDA/CMDE/MDCG Cybersecurity Guidance, IEC 62443, ISO 14971, HIPAA, GDPR) to ensure product compliance.
- Stay current with emerging regulations and standards related to medical device security (e.g., FDA Premarket Guidance, Post-market Cybersecurity Guidance).
- Collaborate with product development teams to embed security controls throughout the design, development, and maintenance phases.
- Self-motivated with a passion for solving problems and a bias for action.
- Ensure that medical device security engineering activities and deliverables (e.g., threat models, security risk assessments, security requirements, security test plans/protocols/reports, SBOM, post-market vulnerability management plans and reports, and cybersecurity labeling) comply with Boston Scientific's global quality system requirements and procedures.
- Collaborate with team on product security needs and requirements; review product security architectures and design specifications.
- Collaborate in planning of software verification and validation strategies.
- Review vulnerability assessments, fuzzing and penetration testing to identify and mitigate risks.
- Ensure continued consistent best practices and processes for secure coding, configuration management, and patching.
- Develop and implement risk mitigation strategies and maintain risk management documentation consistent across the ICTx portfolio.
- Oversee and enhance incident response plans and processes, ensuring rapid and effective resolution of security incidents.
- Drive continuous improvement of vulnerability management, including the evaluation and deployment of necessary patches or updates.
- Work closely with internal stakeholders (Software Development, R&D, Regulatory, IT, etc.) to align on security goals and requirements.
- Participate in internal and external audits, and address findings related to cybersecurity design and risk management processes.
What we’re looking for in you:
Required qualifications
- Bachelor’s degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 5+ years of experience in cybersecurity engineering, with a focus on product development and risk management or Master’s degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 3+ years of experience in cybersecurity engineering, with a focus on product development and risk management
- Proven experience leading security design and architecture reviews for complex, embedded medical devices or similar technologies.
- Demonstrated track record of creating and executing security risk assessments and mitigation strategies.
- In-depth understanding of cybersecurity frameworks (e.g., NIST Cybersecurity Framework).
- Understanding of privacy regulations (HIPAA, GDPR) and their intersection with medical device cybersecurity.
- Strong leadership, decision-making, and team-building capabilities.
- Excellent written and verbal communication skills for interfacing with technical teams, stakeholders, and executive leadership.
- Ability to work collaboratively across multidisciplinary teams, bridging gaps between technical, regulatory, and business functions.
Preferred qualifications
- 5+ years of experience working in the medical device industry or a similarly regulated environment; security architecture or medical device administration experience in healthcare settings is also a plus.
- Hands-on experience with secure coding practices, vulnerability scanning tools, fuzzing, and penetration testing methodologies.
- Knowledge of embedded systems security, wireless communications, network protocols, and PKI.
- Familiarity with FDA regulations and guidance documents for medical devices (e.g., 21 CFR Part 820).
- Working knowledge of SW96/TIR57/TIR97, IEC 62304 (software lifecycle), IEC 60601 (electrical safety), and ISO 14971 (risk management).
- Experience supporting VA Handbook 6500 compliance and ISO/IEC 27001 certification.
- Relevant certifications (e.g., GIAC, OffSec, CISSP, CISM, CRISC) are a plus.
Maximum Salary: $ 156900
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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Boston Scientific Quality Tech II - 1st Shift United States, Minnesota
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Applicants must be authorized to work in the United States without the need for employer sponsorship, now or in the future.
- Establishing category strategies that result in a sustainable competitive advantage.
- Managing strategic supplier relationships in line with company and category expectations
- Negotiating and executing contracts that deliver the best outcomes for Boston Scientific
- Driving sustained year-over-year value improvement related to quality, service, and cost.
- Defining technology roadmaps that align with long-term product and patient needs.
- Collaborating with Supplier Engineering to develop should-cost models.
- Gathering and analyzing market intelligence to report on trends, risks, etc.
- Identifying market and sourcing risks; work with stakeholders to define and execute mitigation plans.
- Providing key data analytics and reporting to support category and supplier strategies
- Supporting the broader sourcing team with data analytics and supplier communications
- Providing source selection recommendations for new products that align with the category strategy.
- Driving early supplier involvement with R&D to achieve development objectives, timelines, and reduce costs.
- Facilitating supplier business reviews; attend on-site supplier visits for assessments, negotiations, business reviews, etc.
- Facilitating the identification and evaluation of new materials and technologies
- Identifying and rationalizing insourcing vs. outsourcing opportunities
- Supporting or leading business process improvement projects
- Providing escalation support to site purchasing teams as required
- Bachelor’s degree in Supply Chain, Engineering, Business, or a related field
- Experience in Sourcing, Supply Chain Management, or Supplier Relationship Management
- Proficient with MS Office Excel and other applications (i.e., Word, PowerPoint, MS Project etc.)
- Ability to travel up to 20%.
- Minimum 2 years of experience in Sourcing, Supply Chain Management, or Supplier Relationship Management
- Master’s Degree or professional certification (i.e., CPSM, CPIM, CSCP, PMP, Lean Six Sigma, etc.)
- Experience sourcing for electronic components or medical devices.
- Experience working in medical device or similar regulated industry.
- Strong data analysis skills, with ability to translate data into strategy
- Ability to take direction and coaching from mentors
- Strong decision-making and negotiation skills, ability to influence internal and external teams.
- Ability to work independently and collaborate with cross-functional teams to complete projects.
- Strong interpersonal skills, with ability to communicate effectively with individuals on all levels.
- Strong critical thinking and analytical skills: process and results-oriented
- Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively.
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
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West Pharma Senior Quality Manager United States, Pennsylvania, Williamsport
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Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.
- Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development.
- As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
- The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same
- Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
- Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible.
- Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings.
- Perform the necessary functions in support of the Williamsport Quality System
- Designated ISO 13485 Management Representative
- Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner.
- In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
- Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations
- QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
- Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
- Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team.
- Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
- Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions.
- Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
- Responsible and accountable for quality departmental budget
- Other duties as assigned
- Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required
- Master’s degree preferred
- 10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry.
- 8+ Years of supervisory experience required.
- 5+ Years of experience working with injection molding processes preferred.
- 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing.
- Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines and other relevant regulatory requirements (e.g. HACCP).
- Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
- Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
- Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
- Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
- Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
- Self-motivated with a proactive attitude and the ability to work effectively
- Project Management experience preferred
- Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
- Excellent written and oral communication skills
- Medical component and device manufacturing require strict adherence to standards.
- Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
- Read and interpret data, information, and documents
- Must maintain the ability to work well with others in a variety of situations
- Must be able to multi-task, work under time constraints, problem solve, and prioritize
- Ability to make independent and sound judgments
- Demonstrates enthusiasm, takes accountability, and drives for results.
- Superior organizational and leadership skills with ability to help team grow and thrive
- Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
- Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
- Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
- Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
- Able to lead and manage the performance of a multi-functional team.
- Able to organize and prioritise tasks, must be detail orientated and self-motivated.
- Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Able to always comply with the company’s safety and quality policy
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In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.
- Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
- Organize and generate detailed quality information reports to show trends and the impact of process improvements.
- Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
- Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
- Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
- Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
- Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
- Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
- Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
- Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
- Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
- Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
- Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
- Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
- Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
- Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
- Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
- Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
- May coordinate the activities of one or more exempt and/or non-exempt employees.
- All other duties as required.
- Bachelor's Degree in Science, Engineering or related field
- 8+ years of relevant work experience required
- 5+ years’ experience in pharmaceutical or medical device environment.
- 2+ years’ experience in a Quality role.
- ASQ CQE certification desirable.
- Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
- Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
- Ability to manage direct report(s), work independently and in a team environment.
- Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
- Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
- Experience with SAP is preferred.
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
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