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. 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 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. Required Qualifications 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. Preferred Qualifications 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. Compensation Requisition ID: 627626 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 positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Additional Eligibility & Requirements Certain US‑based positions, including but not limited to field sales and service roles that call on hospitals and healthcare centers, require acceptable proof of COVID‑19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. This role is deemed safety‑sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. EEO Statement Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Nearest Major Market: Minneapolis Job Segment: Quality Engineer, Pharmaceutical, Senior Quality Engineer, Risk Management, Lean Six Sigma, Engineering, Science, Finance, Management #J-18808-Ljbffr Boston Scientific Gruppe