Key Responsibilities:
- Ensure compliance with internal quality systems and external regulatory requirements (e.g., FDA, ISO 13485, cGMP, EU MDR and other applicable standards)
- Lead and support external inspections and regulatory audits
- Plan, coordinate, and conduct internal audits, including identifying gaps, investigating findings, and driving corrective actions
- Identify areas of non-compliance and drive continuous improvement initiatives
- Act as subject matter expert (SME) for CAPA processes, ensuring effective implementation and timely closure
- Maintain and continuously improve site CAPA processes and systems
- Develop, track, and report CAPA metrics to support management review activities
- Support corrective and preventive action processes across the site
- Collaborate cross-functionally to standardize quality system policies and procedures
- Provide training and guidance to teams on quality system requirements
- Gather and analyze quality system data to support management review and decision making
- Participate in global quality system initiatives and discussions
- Provide quality oversight to analytical laboratory activities, including compliance with cGMP and support for investigations (e.g., OOS/OOT), where applicable
Requirements:
- Bachelor’s Degree in Science, Engineering, or a related field
- Minimum 9 years of experience in a manufacturing environment
- Experience in the medical device industry is desirable
- Experience in: Non-conformance and CAPA management, Management Review processes, Internal and external audits
Required Skills & Knowledge:
- Knowledge of ISO 13485, EU MDR, and FDA regulations
- Knowledge of cGMP and combination product/device regulations
- Lead Auditor certification is an added advantage
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
- Bachelor's Degree in Science, Engineering, or a related field
- Minimum 9 years of experience in a manufacturing environment
- Experience in the medical device industry is desirable
- Experience in Non-conformance and CAPA management, Management Review processes, Internal and external audits
- Knowledge of ISO 13485, EU MDR, and FDA regulations
- Knowledge of cGMP and combination product/device regulations
- Lead Auditor certification is an added advantage
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.
