Senior Supplier Quality Engineer- SFMD Endoscopy

Senior Supplier Quality Engineer- SFMD Endoscopy

Work mode: Hybrid

Onsite Location(s): Marlborough, MA, US, 01752

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 Endoscopy division with a primary focus on capital equipment. The Sr. Supplier Quality Engineer plays a critical role in maintaining compliance with ISO 13485, FDA QSR (21 CFR 820) and other applicable medical device regulations.

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 in the BSC Quality System.
• Investigate and solve non-conformances due to incoming inspection at BSC Distribution Centers.
• Investigate complaints and manage NCEPs at OEM suppliers where the issue is manufacturing related.
• Lead investigations into supplier-related nonconformances and implement effective Corrective and preventive actions (CAPA)
• Provide manufacturing support at external vendors by addressing manufacturing process defects and implementing process improvements utilizing Quality System tools.

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.
• Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
• Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.
• Review and approve Supplier documentation including validation protocols (IQ/OQ/PQ), FMEAs, control plans and inspection methods.

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 in supplier engineering, supplier management, or supplier quality engineering.
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Experience with capital equipment or electronics including product development, servicing, and repair.
• 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%. 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.

Preferred Qualifications:

• 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.