Global Post-Market Quality Engineer Lead

Senior Quality Engineer - Global Post Market Support

Onsite Location(s):
Arden Hills, MN, US 55112

Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high‑performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

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.

Work model, sponsorship:
At Boston Scientific, we value collaboration and synergy. This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills, MN;
Maple Grove, MN; or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• 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 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.

• 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.

• 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.

Requisition

Minimum Salary: $85,000

Maximum Salary: $161,500

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 an annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non‑sales roles may also include variable compensation, i.e., an annual bonus target and long‑term incentives (subject to plan eligibility and other requirements).

For MA…