Supplier QA Engineer II - External Operations ENDO

Boston Scientific • Georgetown, MA

9d • $75,100 - $142,600 • Hybrid

About The Position

The Supplier Quality Engineer II will support Boston Scientific’s External Operations organization, which oversees a global network of suppliers that manufacture sourced finished medical devices for distribution. The role supports Endoscopy division products, primarily single-use devices and capital equipment, as well as medical and non-medical accessories or products. It has a primary commitment to patient safety and works with internal and external cross-functional teams to improve supplier manufacturing processes. The position is hybrid, with a minimum of three onsite days and up to two remote days per week, based at the corporate site in Marlborough, Massachusetts. Domestic and international travel may be required up to 25%. The role is safety-sensitive and candidates are subject to prohibited substance testing.

The position manages supplier quality and sustaining activities, including quality issues, supplier corrective actions, audits, process and design changes, non-conformances, complaints, and supplier change impact assessments. It also supports post-market investigations, documentation changes, project planning, and continuous improvement. For new product development, the engineer executes quality deliverables for integrating and onboarding suppliers and finished medical devices into Boston Scientific’s Quality System, working with cross-functional teams on quality plans, agreements, specifications, qualifications, and validations.

As a quality system champion, the engineer supports internal and external audits, helps develop and implement policies and procedures, identifies opportunities to improve quality systems and processes, and promotes compliance with company policies and standard operating procedures. Compensation is listed as $75,100 to $142,600, with actual compensation determined by relevant factors. Eligible compensation arrangements may include annual bonuses, long-term incentives, overtime, or shift differentials as applicable.

Requirements

• Bachelor’s degree in engineering and at least 1 year of relevant experience in supplier interaction, quality systems, or regulated processes.
• Experience in a medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management ability, including influencing cross-functional global teams across 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.
• Strong communication skills, including the ability to tailor information to the intended audience.
• Ability to learn and use new software applications, such as PLM and ERP systems.
• Ability 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 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.
• 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 supplier quality issues 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, and coordinate evaluations of proposed supplier changes.
• Plan and lead supplier audits, including scheduling, investigation and evaluation of findings, reporting, follow-up, and confirmation of actions.
• Manage sustaining quality issues and supplier process and design change impacts in accordance with Boston Scientific and supplier quality system requirements.
• Investigate non-conformances identified through incoming inspection at Boston Scientific Distribution Centers.
• Support Design Quality Assurance investigations involving post-market signals, field actions, and Product Inquiry Reports related to suppliers.
• Investigate complaints and manage NCEPs at OEM, contract manufacturer, and other suppliers when issues are manufacturing-related.
• Support supplier change impact assessments for supplier process changes.
• Perform and support finished-good documentation changes for design changes and labeling updates.
• Lead projects, meet milestones, develop clear project plans, and create contingency plans.
• Lead or support continuous improvement opportunities at Boston Scientific points of use.
• Execute SFMD Plan deliverables for integrating or onboarding suppliers and related products into Boston Scientific’s Quality System.
• Lead 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 and validation, and process validations.
• Support Material Controls requests during external regulatory body audits and lead or support Material Controls internal audits.
• Collaborate with corporate and regional supplier quality teams to develop, review, and implement policies, procedures, and guidelines.
• Identify and advise management on potential quality system and process improvements.
• Champion compliance with company policies and standard operating procedures.

What This Job Offers

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