Boston Scientific
About the role
Boston Scientific is seeking an experienced and strategic
Quality Engineer
to serve as the CAPA program owner and drive continuous improvement across the organization. This high-impact role will lead root cause investigations, implement effective corrective and preventive actions (CAPAs), and ensure compliance with regulatory and quality standards. You'll collaborate cross-functionally and influence process enhancements that strengthen our Quality Management System.
Work model, sponsorship, relocation At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office five days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Responsibilities
Serve as the CAPA program owner, managing all phases of the CAPA lifecycle from initiation to closure.
Lead or support complex root cause investigations using structured problem‑solving tools such as 5 Whys, Fishbone diagrams, 8D, and FMEA.
Facilitate cross‑functional teams to identify, analyze, and eliminate root causes of quality issues.
Partner with Engineering, Manufacturing, Regulatory, and Operations to develop and implement robust corrective and preventive actions.
Monitor CAPA effectiveness, track metrics, and identify quality trends and opportunities for improvement.
Ensure CAPA documentation complies with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other applicable regulatory standards.
Support internal and external audits by providing CAPA documentation and participating in audit activities.
Assist with training team members on CAPA processes and quality system requirements.
Contribute to ongoing continuous improvement efforts and quality system enhancements.
Perform other duties as assigned.
Required qualifications
Bachelor's degree in Engineering, Life Sciences, or a related field.
Minimum of 5 years' experience in Quality Engineering, preferably in a regulated industry (e.g., medical devices or pharmaceuticals).
Proven experience managing CAPA processes and leading root cause investigations.
Strong understanding of regulatory requirements including FDA QSR, ISO 13485, ISO 14971, and EU MDR.
Proficiency with quality tools and methodologies such as Six Sigma, Lean, and Kaizen.
Experience with electronic Quality Management Systems (eQMS), such as TrackWise or similar platforms.
Excellent communication, documentation, and project management skills.
Preferred qualifications
Certified Quality Engineer (CQE), Six Sigma Green or Black Belt, or similar certification.
Experience in complaint handling, nonconformance investigations, and post‑market surveillance.
Salary Minimum Salary: $72,800 Maximum Salary: $138,300
Equal Opportunity Employer Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
COVID‑19 Vaccination and Prohibited Substance Test Please be advised that certain US‑based positions, including but not limited to 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. This role is deemed safety‑sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.
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Quality Engineer
to serve as the CAPA program owner and drive continuous improvement across the organization. This high-impact role will lead root cause investigations, implement effective corrective and preventive actions (CAPAs), and ensure compliance with regulatory and quality standards. You'll collaborate cross-functionally and influence process enhancements that strengthen our Quality Management System.
Work model, sponsorship, relocation At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office five days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Responsibilities
Serve as the CAPA program owner, managing all phases of the CAPA lifecycle from initiation to closure.
Lead or support complex root cause investigations using structured problem‑solving tools such as 5 Whys, Fishbone diagrams, 8D, and FMEA.
Facilitate cross‑functional teams to identify, analyze, and eliminate root causes of quality issues.
Partner with Engineering, Manufacturing, Regulatory, and Operations to develop and implement robust corrective and preventive actions.
Monitor CAPA effectiveness, track metrics, and identify quality trends and opportunities for improvement.
Ensure CAPA documentation complies with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other applicable regulatory standards.
Support internal and external audits by providing CAPA documentation and participating in audit activities.
Assist with training team members on CAPA processes and quality system requirements.
Contribute to ongoing continuous improvement efforts and quality system enhancements.
Perform other duties as assigned.
Required qualifications
Bachelor's degree in Engineering, Life Sciences, or a related field.
Minimum of 5 years' experience in Quality Engineering, preferably in a regulated industry (e.g., medical devices or pharmaceuticals).
Proven experience managing CAPA processes and leading root cause investigations.
Strong understanding of regulatory requirements including FDA QSR, ISO 13485, ISO 14971, and EU MDR.
Proficiency with quality tools and methodologies such as Six Sigma, Lean, and Kaizen.
Experience with electronic Quality Management Systems (eQMS), such as TrackWise or similar platforms.
Excellent communication, documentation, and project management skills.
Preferred qualifications
Certified Quality Engineer (CQE), Six Sigma Green or Black Belt, or similar certification.
Experience in complaint handling, nonconformance investigations, and post‑market surveillance.
Salary Minimum Salary: $72,800 Maximum Salary: $138,300
Equal Opportunity Employer Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
COVID‑19 Vaccination and Prohibited Substance Test Please be advised that certain US‑based positions, including but not limited to 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. This role is deemed safety‑sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.
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