Senior Quality Engineer - Global Post Market Support

Boston Scientific • Arden Hills, MN

11h • Hybrid

About The Position

This global role is responsible for developing and maintaining standardized complaint handling processes for post-market support teams across all Boston Scientific divisions. You will partner with global and divisional stakeholders to drive regulatory compliance, operational excellence and continuous improvement across complaint handling systems and processes. Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.

Requirements

• Minimum of a bachelor’s degree.
• Minimum of 5 years' experience in quality within the medical device or pharmaceutical industry.
• Strong understanding of post-market regulatory requirements.

Nice To Haves

• Demonstrated problem-solving, influencing and critical thinking skills.
• Experience with project management methodologies and tools.
• Experience working in a global or multi-divisional environment.
• Experience with statistical process control (SPC) and other statistical tools for quality data analysis, including application to business processes.
• ASQ Certified Quality Engineer (CQE), Lean Six Sigma or similar certification.
• Working knowledge of medical device regulations, including EU MDR, ISO 13485 and ISO 14971.

Responsibilities

• Collaborate with divisional and global teams on complaint handling projects and corrective and preventive actions (CAPAs).
• Support regulatory compliance through effective training, documentation and audit readiness activities.
• Evaluate the adequacy and compliance of systems, operations and practices against regulatory requirements and internal procedures; serve as a subject matter expert during internal and external audits.
• Coordinate with global and divisional teams to develop and maintain clear documentation, including standard operating procedures (SOPs), work instructions and control plans to ensure consistency and compliance.
• Provide technical leadership to a network of global and divisional subject matter experts responsible for monitoring complaint handling processes.
• Partner cross-functionally with complaint handling, risk management and IT/systems teams to ensure alignment and effectiveness.
• Lead and support root cause investigations for recurring process failures and implement effective CAPAs.
• Drive continuous improvement initiatives using quality engineering principles and critical thinking, ensuring alignment with regulatory requirements.
• Define and establish process requirements based on customer needs, translating process outputs into actionable insights for downstream stakeholders.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance
• 401k
• Employee stock purchase plan
• Professional development
• Learning and development program
• Tuition reimbursement
• Flexible scheduling
• Paid holidays
• Wellness programs

What This Job Offers

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