Supplier QA Engineer II - External Operations ENDO
Supplier Quality Engineer II at Boston Scientific managing quality for sourced finished medical devices in the Endoscopy division: supplier audits, CAPA/SCAR management, nonconformance investigations, and new-supplier onboarding, working hybrid (3 days onsite) in Marlborough, MA. Requires an engineering degree, regulated-industry experience, and process validation/CAPA/risk-management experience.
- Compensation
- $75.1K–$142.6K / yr
- Location
- Marlborough US-MA, United States | N/A
- Work setup
- Onsite
- Seniority
- Middle
- Employment
- Not specified
- Experience
- 1+ years
- Category
- Qa
- Posted
Skills
Must have
- BS degree in engineering with minimum 1+ years of relevant experience in supplier interaction, quality systems, or regulated processes
- 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, CAPA, SCAR
- Ability to work independently; organized and self-driven
- Articulate communicator; adept at packaging and 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%
Nice to have
- Fluent in Mandarin
- MS degree in engineering
- 5+ years of medical device engineering experience in design, manufacturing, or supplier quality
- Medical device industry experience
- Problem solving and project management experience
- 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)
- Working knowledge of EU MDR, FDA QMSR, IEC 60601, and ISO 14971
Full description
Recruiter: Spencer Gregory Hale
Supplier Quality Engineer II – External Operations ENDO
Boston Scientific's hybrid workplace incorporates an onsite 3 day minimum with optional 2 remote days. By applying to this position, you will be located and reporting to the corporate site in Marlborough, MA.
Remote Eligible: Hybrid
Onsite Location(s): Marlborough, MA
About the role:
The External Operations organization focuses on Sourced Finished Medical Device (SFMD) at Boston Scientific and is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer II will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes. In this role, you will support SFMD products within Endoscopy division with a primary focus on Single-Use Devices and Capital Equipment. Additionally, the resource will support medical and non-medical accessories or products.
Your responsibilities include:
Sustaining Engineering:
- 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 supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
- Manages sustaining quality issues, process change impacts, and design change implementations for suppliers within the BSC quality system requirements as well as supporting any requirements from the supplier’s Quality system.
- Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
- Supports Design Quality Assurance with post market signals, Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
- Investigates complaints and manages NCEPs at OEM suppliers, CM suppliers and other categories of suppliers where the issue is manufacturing-related.
- Supports Supplier Change Impact Assessments for process changes at suppliers.
- Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.