Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
Senior Supplier Quality Engineer- Sourced Finished Medical Devices
About the role:
The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes.
Your responsibilities will include:
- Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
- Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
- Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
New Product Development:
- Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
- Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
Quality System Champion:
- Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
- Identifies and advises management on potential improvements to quality systems and processes in the company.
- Champions 100% compliance to company policies and SOP’s.
What we’re looking for in you:
- BS degree in engineering or related technical field with minimum of 2-5 years of relevant experience.
- Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
- Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.
- Experience in process validation, design controls, risk management, and CAPA.
- Ability to work independently; organized and self-driven.
- Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
- Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
- Domestic and international travel up to 25%. Note: COVID-19 precautions currently restrict travel. At Boston Scientific, our priority is to protect and aid the health and safety of our employees, our physician customers, and their patients.
- 7+ years of medical device engineering experience preferred.
- Leadership experience on a materials or service commodity team.
- Lead auditor of quality systems experience (ISO 13485 or similar).
- ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired.