Purpose Statement
Serves as a Quality representative to improve awareness, visibility, communication, and quality initiatives in support of departmental, functional, site, divisional, and corporate quality goals.
Key Responsibilities:
- Drive changes in procedures and standards to improve work efficiency and maintain quality.
- Ensure implementation of internal requirements and external laws, regulations, guidance, and standards applicable to Quality Systems.
- Implement, coordinate, and continuously review CAPA, Internal Audit, and Corporate Compliance programs.
- Facilitate CAPA management across the organization and participate in global CAPA meetings.
- Conduct Internal Audits, identify compliance gaps, and support external audits.
- Conduct Quality System training for employees.
- Lead Quality System improvement initiatives using appropriate problem-solving and continuous improvement methodologies.
- Provide Quality Assurance support for analytical laboratory activities, including Analytical Batch Release, Raw Materials (API), Finished Goods, Stability Testing, and laboratory investigations (OOS, OOT, LIR), ensuring compliance with cGMP and regulatory requirements.
Requirements:
- Degree qualified in Science/Engineering.
- Experience in the medical device industry is desirable.
Required Skills and Knowledge:
- CAPA and Non-Conforming Event management.
- Internal and External Audit experience.
- Analytical Batch Release.
- Pharmacopeia Review and Annual Product Review.ISO 13485, EU MDR, FDA Regulations.
- cGMP and Combination Device Regulations.
- Lead Auditor qualification is desirable.
About Us
As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Skills Required
- Degree in Science or Engineering
- Experience in the medical device industry
- CAPA and Non-Conforming Event management
- Internal and External Audit experience
- Analytical Batch Release
- Pharmacopeia Review
- Annual Product Review
- ISO 13485
- EU MDR
- FDA Regulations
- cGMP
- Combination Device Regulations
- Lead Auditor qualification
Boston Scientific Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Boston Scientific and has not been reviewed or approved by Boston Scientific.
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Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical, dental, vision, life, and disability insurance alongside mental health resources. Family planning support and broader care navigation offerings further strengthen the health-related value of the package.
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Retirement Support — Retirement benefits stand out through a 401(k) match described as best-in-class and supported by profit sharing and an employee stock purchase plan. High participation in retirement programs is also highlighted as part of the overall financial benefits footprint.
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Leave & Time Off Breadth — Time off is described as generous, with reports of 20+ vacation days and up to four weeks in some roles, plus paid holidays and sick leave. Longer-term options such as extended unpaid family leave and a personal enrichment sabbatical expand flexibility beyond standard PTO.
Boston Scientific Insights
What We Do
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.
