Senior Quality Supervisor Details

Senior Quality Supervisor

Work mode: Hybrid

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

Additional Location(s): US-MN-Arden Hills

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

As the Senior Quality Supervisor, Device Tracking, you will lead a high‑performing team responsible for global medical device tracking operations and data management that help ensure patient safety, regulatory compliance and business continuity.

In this highly visible leadership role, you will partner across Quality, Regulatory Affairs, IT, Operations, Distribution, Customer Service and Commercial teams to ensure the integrity of device tracking processes while driving continuous improvement and operational excellence.

• Lead, coach and develop a team of Business Process Administrators supporting global medical device tracking operations while fostering a culture of accountability, collaboration and continuous improvement.
• Drive the day-to-day execution of device tracking activities while ensuring compliance with FDA regulations, global quality system requirements and internal procedures.
• Oversee data quality, data integrity and records management within Global Medical Device Tracking (GMDT) and other enterprise systems.
• Lead continuous improvement initiatives, including process optimization, automation opportunities and system enhancements that improve operational performance.
• Partner with Regulatory Affairs and Product Teams to support new product introductions, acquisitions, regulatory commitments and device tracking assessments.
• Represent the Device Tracking function on cross‑functional initiatives and evaluate the impact of business process and system changes.
• Monitor and improve operational performance using key performance indicators (KPIs), service‑level agreements (SLAs) and quality metrics.
• Lead investigations into process issues and data discrepancies, implementing effective corrective and preventive actions (CAPAs) that reduce risk and improve performance.
• Support internal and external audits, regulatory inspections and quality management reviews.
• Build organizational capability through coaching, performance management, succession planning and employee development.
• Partner effectively across Quality, Regulatory Affairs, IT, Operations, Distribution, Customer Service and Commercial organizations to deliver business objectives.
• Demonstrate a commitment to patient safety and product quality by ensuring compliance with applicable regulatory requirements, Boston Scientific's Quality System and established quality processes.

• Associate degree in Business, Quality, Engineering, Life Sciences, Information Technology or a related field with a minimum of 7 years' relevant experience; or Bachelor's degree in Business, Quality, Engineering, Life Sciences, Information Technology or a related field with a minimum of 5 years' relevant experience.
• Minimum of 2 years' experience leading employees or cross‑functional project teams.
• Working knowledge of FDA 21 CFR Part 821 and ISO 13485 requirements.
• Experience supporting quality systems, process controls, audits, CAPAs, change management or other compliance‑related activities.
• Demonstrated ability to lead process improvements, manage operational metrics and drive execution of business objectives.
• Demonstrated analytical and problem‑solving skills, with the ability to make sound decisions in a regulated environment.
• Demonstrated ability to communicate effectively and build strong partnerships across cross‑functional teams and organizational levels.

• Experience with medical device tracking, post‑market surveillance, complaint handling or patient data management.
• Experience using GMDT (Global Medical Device Tracking), SAP, Salesforce, Jira or similar enterprise systems.
• Lean Six Sigma certification or demonstrated continuous improvement experience.
• Experience supporting acquisitions, system implementations or quality system integrations.
• Experience leading global teams or outsourced operations.

Minimum Salary: $85,000

Maximum Salary: $161,500

631461

Minneapolis

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.