Quality Assurance Specialist 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 Senior Regulatory Affairs Specialist United States, Pennsylvania, West Whiteland Township
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The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.
- Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
- Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
- Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
- Provide leadership to cross functional teams for regulatory issues and questions.
- Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
- Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
- Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
- Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
- Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
- Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required
- Bachelor’s degree or equivalent experience is required
- Master’s degree or PhD in science, math, engineering, or related discipline preferred
- Minimum 5 years of relevant experience
- 2+ years of medical device regulatory experience preferred
- Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
- History of successful international device registration,EU MDR technical documentation and/or US 510(K) authoring experience
- Advanced knowledge of ISO 13485
- Advanced knowledge of product life cycle, product development process, design control and change control
- Experience interacting with government agencies
- Excellent oral communication, technical writing, and decision-making skills
- Attention to detail with planning, time management and organizational skills
- Regulatory compliance competency including Quality Systems
- Experience with administration and safety systems preferred
- Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement.
- Ability to comprehend principles of math, science, engineering, and medical device use.
- Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
- Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
- Ability to review, collate, describe, and summarize scientific and technical data.
- Ability to organize complex information and combine pieces of information to form general rules or conclusions.
- Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
- Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
- Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
- Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
- Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.
- Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
- Ability to verbally communicate ideas and issues effectively to other team members and management.
- Ability to write and record data and information as required by procedures.
- Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).
- Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred
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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 Meeting Planning Specialist United States, Minnesota
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About the role:
This position is responsible for the strategic planning and execution of PI Vascular Medical Affairs and Professional Education meetings.
Your responsibilities will include:
- Manage program logistics including sleeping rooms, flights, food and beverage, ground transportation, meeting room set-up, budgets, attendee management, communications, and onsite materials.
- Build and manage event registration processes using Cvent, ensuring accurate data management, providing attendee support, generating reports, and collaborating with cross-functional teams for seamless event execution.
- Manage surveys and evaluate feedback from the training programs and working closely with the Program Mangers to make changes to our current programs to ensure use of both best practice and new innovative education methods.
- Ensures consistency and collaboration for meetings while following established guidelines, processes, and tools.
- Defines, tracks, and maintains budgets while ensuring cost-saving measures and spending are within allocated amounts.
- Maintains and enhances knowledge of the meetings & events industry trends and best-in-class practices.
- Partners with and manages vendors to ensure objectives are being met.
- Runs reports and presents data metrics to leadership for all Medical Affairs & Ed as requested.
- Planning and coordinating other projects that contribute to the accomplishment of the clinical education goals and objectives
- Communicates proactively to stakeholders across all levels of the organization.
- Educates cross-functional teams, provides direction, and establishes solutions where appropriate.
- Ensures all company policies and compliance practices are being followed.
Required qualifications:
- Bachelor’s degree or equivalent
- A minimum of 5 years of related experience in event/meeting planning
- Proven history of working on international HCP programs and outside of the US compliance policies.
- Candidate must have appetite for innovation and continuous learning.
- Ability to develop and maintain relationships with physician customers and sales teams.
- Works independently on complex meetings
- Must be a strong communicator and collaborator
- Ability to develop new processes and adjust practices to meet business needs.
- Strong organizational and multitasking skills with meticulous attention to detail.
- Ability to handle high volume workload and fast pace; manage stress
- Strong project management and organization skills; detail-oriented
- Proficient in the use of Microsoft Office Suite, Cvent and SalesForce.com
- Domestic travel required up to 20%
- Ability to lift 20lbs
- Ability to work extended hours/weekend hours, as needed
Preferred qualifications:
- Experience in the medical device industry
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.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
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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Boston Scientific Senior Regulatory Affairs Specialist - Endoscopy United States, Massachusetts, Marlborough
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At Boston Scientific, you’ll find purpose through your life’s work—improving lives with innovative medical solutions. Within our, we develop and deliver advanced technologies that diagnose and treat diseases of the digestive system, airway, and lungs. Our portfolio includes solutions in
We continue to invest in innovation across both established platforms and new pipeline development. As a, you will play a key role in supporting the global regulatory strategy for our Endoscopy product lines—from new product introductions to sustaining and post-market activities.
• Develop and implement regulatory strategies for new and modified medical devices
• Serve as a core team member on development projects, providing regulatory input throughout the product development lifecycle
• Draft and submit U.S. and EU regulatory filings for new and modified medical devices
• Review device labeling and advertising materials to ensure regulatory compliance and alignment with submission claims
• Review change notifications and conduct regulatory impact assessments for product and manufacturing changes
• Support associated global submissions in accordance with applicable regulations
• Serve as company representative in communications with regulatory agencies regarding submission strategy, testing requirements, and clarification or follow-up during review
• Support and maintain Boston Scientific's Quality initiatives in accordance with our Quality Policy
• Continuously identify and support opportunities for quality improvement across the organization
• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
•in Regulatory Affairs within the medical device industry
• Strong working knowledge of
• General understanding of
• Familiarity with regulations related to the conduct of clinical trials
• Ability to manage multiple regulatory projects simultaneously
• Experience preparing and submitting, or international registrations
• Proficiency with Microsoft Office tools
• Strong analytical, research, and problem-solving skills
• Excellent written and oral communication, technical writing, and editing abilities
• Demonstrated ability to work independently with minimal supervision
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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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 AF Solutions Clinical Specialist II - Wichita KS United States, Kansas, Wichita
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Your responsibilities will include:
andthrough compelling presentations, hands-on training, and clinical support
Traveling regularly to hospitals and clinics to assess customer needs, deliver procedural support, and guide physicians on best practices for patient care
Building strong relationships with clinical and administrative stakeholders to identify opportunities for therapy adoption and market expansion
Collaborating across cross-functional teams—sales, marketing, clinical research, and training—to deliver strategic insights and implement territory-specific plans
Championing new product launches and acting as a resource for competitive intelligence within the electrophysiology and structural heart space
Supporting market development initiatives by connecting with key opinion leaders, external fellows, and referring physicians to promote awareness and utilization
Contributing to talent development and mentoring new team members as needed, while embracing Boston Scientific’s inclusive and high-performance culture
Monitoring clinical trial activity in your area, including interest visits, site initiations, and protocol education
Ensuring compliance with regulatory requirements and internal procedures by maintaining current knowledge of clinical trial protocols and standards
Participating in on-call coverage as required to support critical case needs
Required qualifications:
Minimum of a bachelor’s degree or equivalent experience.
Minimum of 2 years' experience in clinical cardiology, medical device sales, or a related industry.
Preferred qualifications:
Experience in structural heart, atrial fibrillation, or electrophysiology strongly preferred.
Demonstrated technical aptitude with the ability to communicate complex clinical and product information effectively.
Advanced degree in healthcare or business is a plus.
The anticipated annualized base amount or range for this full time position will be, 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.
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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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