Quality Technician jobs
West Pharma Quality Project Manager United States, Pennsylvania, West Whiteland Township
Share
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.
These jobs might be a good fit
Boston Scientific Quality Engineer II United States, Minnesota
Share
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.
These jobs might be a good fit
Boston Scientific Senior Design Quality Cybersecurity Engineer United States, Minnesota
Share
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.
These jobs might be a good fit
Boston Scientific R&D Technician IV ICTx United States, Minnesota
Share
About the role:
Assist R&D engineers, scientists, and/or teams in developing and analyzing products, materials, processes, or equipment. This level of position requires an extensive knowledge base, high independence, a demonstrated ability to follow detailed instructions, and a deep aptitude for learning.
As an R&D Technician IV at Boston Scientific, you’ll be hands-on in shaping the next generation of catheter-based medical devices. In this senior role, you’ll work closely with engineers and cross-functional teams to build prototypes, run tests, and solve technical challenges that directly impact patient care. You’ll have the independence to drive your own work while contributing to a culture of innovation and collaboration.
Your responsibilities will include:
Execute assigned tasks for project deliverables.
Develop solutions and contribute to initial design, testing, and process concepts.
Construct prototype products and/or detailed test methods and fixtures from concepts.
Organize, coordinate, execute, and document testing of prototypes/materials with minimal engineering guidance.
Develop new test methods and/or make revisions to existing test methods.
Coordinate procuring and qualification of new or modified test equipment.
Work with internal resources and external vendors to identify and obtain supplies and services.
Contribute to problem-solving and root cause investigations (DOE, FMEA, CAPA)
Train/Coach peers on their job's technical aspects, including interpreting and rationalizing results (i.e., statistics, DOE).
Required qualifications:
- 3 years of experience with a High School diploma, or an equivalent combination of education/work experience
Preferred qualifications:
- 5 years of similar experience
- Experience with complex catheter design, assembly, prototyping, and testing
- Experience with electromechanical products and test systems
- Medical device test method and fixture development experience
- Strong organizational skills and self-motivation
- Strong track record handling detailed oriented work
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.
These jobs might be a good fit
Boston Scientific Quality Tech II - 1st Shift United States, Minnesota
Share
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.
These jobs might be a good fit
West Pharma Senior Quality Manager United States, Pennsylvania, Williamsport
Share
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
These jobs might be a good fit
Boston Scientific R&D Technician - 1st Shift United States, Minnesota
Share
Your responsibilities will include:
- Internal Customer interface to answer questions regarding the tool crib space as well as fulfilling orders for storage needs as well as product requests.
- Learn and apply standard business practices for customer need and processes.
- Maintain training compliance requirements for position.
- Assist engineering teams in obtaining the necessary supplies and components.
- Assist in the set-up of mezzanine storage and organization
- Assist with problem-solving.
Required qualifications:
- High School diploma or an equivalent combination of education/work experience
The anticipated annualized base amount or range for this full time position will be$ to $, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.
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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
These jobs might be a good fit
Share
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.
These jobs might be a good fit
