Senior Quality Engineer - Global Post Market Support

Boston Scientific • Maple Grove, MN

15h • Hybrid

About The Position

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. 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.

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

• The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.
• Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
• At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
• Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
• Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees