Supplier QA Engineer II - External Operations ENDO

Boston Scientific • Marlborough, MA

8d • $75,100 - $142,600 • Hybrid

About The Position

The Supplier Quality Engineer II works within Boston Scientific’s global External Operations organization, which oversees suppliers manufacturing sourced finished medical devices for distribution. This role supports Sourced Finished Medical Device products in the Endoscopy division, primarily single-use devices and capital equipment, as well as medical and non-medical accessories or products. The position is based at the corporate site in Marlborough, Massachusetts, with a hybrid schedule requiring at least three onsite days per week and up to two optional remote days.

The role demonstrates a primary commitment to patient safety and collaborates with internal and external cross-functional teams to improve supplier manufacturing processes. It oversees sustaining supplier quality activities, including supplier quality issues, corrective actions, audits, changes, complaints, nonconformances, and continuous improvement. It also executes quality deliverables to onboard finished medical device suppliers and products into Boston Scientific’s Quality System, and supports internal and external audit and quality-system activities.

Requirements

• Bachelor’s degree in engineering and at least 1 year of relevant experience in supplier interaction, quality systems, or regulated processes.
• Experience in medical device, automotive, aeronautical, semiconductor, or another regulated industry.
• Ability to influence cross-functional global teams spanning Quality, Operations, R&D, and Sourcing.
• Experience with process validation, design controls, risk management, CAPA, and SCAR.
• Ability to work independently; organized and self-driven.
• Articulate communication skills and the ability to tailor information to the intended audience.
• Ability to rapidly learn and use new software applications, such as PLM and ERP systems.
• Willingness to travel domestically and internationally up to 25%.

Nice To Haves

• Fluency in Mandarin.
• Master’s degree in engineering.
• Five or more years of medical device engineering experience, preferably 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 experience with quality systems such as ISO 13485 or similar.
• ASQ certification, such as CQE, CBA, SSGB, or SSBB.
• Working knowledge of EU MDR, FDA QMSR, IEC 60601, and ISO 14971.

Responsibilities

• Evaluate and communicate quality issues to suppliers and use systematic problem-solving methods to identify, prioritize, and resolve them.
• Review and approve supplier corrective action plans and documentation verifying their effectiveness.
• Assess supplier capabilities through onsite visits and technical discussions.
• Coordinate evaluation of proposed supplier changes and support supplier change impact assessments for process changes.
• Plan and lead supplier audits for compliance with regulatory standards and Boston Scientific requirements, including scheduling, investigation, evaluation of findings, reporting, follow-up, and confirmation of follow-up actions.
• Manage sustaining quality issues, process-change impacts, and supplier design-change implementations within Boston Scientific and supplier quality-system requirements.
• Investigate nonconformances identified through incoming inspection at Boston Scientific Distribution Centers.
• Support Design Quality Assurance with post-market signals, field actions, and product inquiry reports by investigating supplier-related or supplier-caused quality issues.
• Investigate complaints and manage NCEPs at OEM, contract manufacturer, and other suppliers when issues are manufacturing-related.
• Support and perform finished-good documentation changes for ongoing design changes or labeling updates.
• Lead projects, meet milestones, create clear project plans, and develop contingency plans.
• Lead or support continuous-improvement opportunities that improve efficiency and effectiveness at Boston Scientific points of use.
• Execute Sourced Finished Medical Device plan deliverables for integrating or onboarding suppliers and related products into Boston Scientific’s Quality System.
• Lead Sourced Finished Medical Device 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 and validation, and process validations.
• Support Material Controls requests for external regulatory-body audits and lead or support Material Controls internal audits.
• Collaborate with corporate and regional supplier quality organizations to develop, review, and implement policies, procedures, and guidelines.
• Identify and advise management on potential improvements to company quality systems and processes.
• Champion full compliance with company policies and standard operating procedures.

Benefits

• Core and optional employee benefits are offered; specific benefits are not listed in the posting.
• Compensation for eligible exempt, non-sales roles may include an annual bonus target and long-term incentives, subject to plan eligibility and requirements.
• Compensation for eligible non-exempt, non-sales roles may include variable compensation such as overtime or shift differential and an annual bonus target, subject to plan eligibility and requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level