Location
Marlborough, MA | United States
Job description
Recruiter: Spencer Gregory Hale
Senior Supplier Quality Engineer - SFMD Urology
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. In this role, you will support SFMD products within the Lumenis acquisition in the Urology division with a primary focus on Single-Use Devices and capital equipment accessories.
Hybrid for the following locations: Marlborough, MA, Minneapolis, MN, and Ireland
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 Lumenis Quality system, the hybridized BSC-Lumenis Quality System, and in the BSC Quality System after products are successfully integrated.
- Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
- Supports Design Quality Assurance with 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 and CM 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.
- Leads projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process.
New Product Development:
- Execute SFMD Plan deliverables for integration of acquired company’s suppliers and products into BSC’s Quality System.
- 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:
Minimal Qualifications:
- BS degree in engineering or technical field with minimum of 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, CAPA, SCAR.
- 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%.
Preferred Qualifications:
- 7+ years of medical device engineering experience preferred.
- 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) desired.
Requisition ID: 577680
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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