The Role
Lead quality engineering activities for medical device manufacturing including root cause analysis, CAPA/NCEP investigations, validation engineering, technical data review, supplier and customer complaint handling, regulatory compliance (QSR/ISO/MDD), and mentoring other QA staff while driving continuous improvement.
Summary Generated by Built In
Key Responsibilities
- Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
- Read and interpret technical drawings, procedures, and protocols.
- Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
- Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
- Participates in Customer Complaints investigation for areas under their control.
- Document investigation findings in analysis report on GCS2.
- Become a trainer for the Software related with complaints handling process (GCS2), as required.
- Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
- Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.
- Is viewed as a leader in the areas of QSR and ISO/MDD standards within ones own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decision.
- Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements.
- Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
- Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
- Champions continuous improvement and innovation from a quality perspective within the department right from vendor selection/approval through to customer awareness/satisfaction.
- Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department and LRP objectives.
- Gives technical guidance to Quality Engineers, Associate Quality Engineers, technician and inspection staff.
- Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
- Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.
- Is familiar with the internal auditing process.
- Bachelor's degree or higher, preferably in an Engineering discipline.
- Minimum 9 years of experience in Operations Quality. Prior experience in the medical device industry is preferred.
- Strong understanding of quality operations fundamentals, regulatory requirements, and quality systems.
- Experience working in regulated manufacturing environments.
- Strong analytical thinking and decision-making capabilities with the ability to solve complex quality issues.
- Ability to work effectively across multiple functions and stakeholders.
- Resolves issues using standard problem-solving tools and a strong understanding of quality operations fundamentals.
- Product risk assessment.
- Data analysis to identify root causes and drive solutions.
- Effective communication of findings and recommendations.
- CAPA, NCEP, and Failure Mode Investigation experience.
- Validation engineering and process validation expertise.
- QSR, ISO, and Medical Device regulatory knowledge.
- Root cause analysis and corrective/preventive action implementation.
- Technical review and approval of operational, test, and validation data.
- Cross-functional collaboration and stakeholder management.
- Supplier quality and customer complaint investigation experience.
- Experience in product transfer will be 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 Engineering or higher
- Minimum 9 years experience in Operations Quality
- Prior experience in the medical device industry
- Strong understanding of quality operations fundamentals, regulatory requirements, and quality systems
- Experience working in regulated manufacturing environments
- Strong analytical thinking and decision-making capabilities
- Ability to work effectively across multiple functions and stakeholders
- CAPA, NCEP, and Failure Mode Investigation experience
- Validation engineering and process validation expertise
- Knowledge of QSR, ISO, and Medical Device regulatory requirements (MDD)
- Root cause analysis and corrective/preventive action implementation
- Technical review and approval of operational, test, and validation data
- Cross-functional collaboration and stakeholder management
- Supplier quality and customer complaint investigation experience
- Experience in product transfer
- Trainer for GCS2 complaints handling software (as required)
- Familiarity with internal auditing processes
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.
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The Company
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.
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