Senior Process Quality Manager

About the role

Boston Scientific is seeking a Senior Process Quality Manager to lead quality improvement initiatives across manufacturing processes. The role combines strategic planning, project execution, and hands‑on supervision of In‑Process Quality Engineers to ensure regulatory compliance and product excellence.

Key responsibilities

• Coordinate activities of Quality Engineering and In‑Process Quality Engineering teams.
• Support new product and process transfer projects, including PFMEA review.
• Plan, execute, and monitor projects aimed at preventing in‑process defects.
• Design and implement robust process control strategies.
• Facilitate Quality Control supervision through Quality Engineers and Supervisors.
• Review and approve quality system documents, investigations, and regulatory submissions.
• Deliver training on quality technologies and best practices.
• Create or improve procedures to ensure regulatory compliance.
• Act as Subject Matter Expert for multiple sections of the Quality Management System (e.g., CAPA, Process Validation, Traceability).
• Participate as a core team member in new product transfer processes.
• Administer NCEP system activities, including investigations and MRB coordination.

Required profile

• Extensive experience in manufacturing quality management, preferably in medical devices.
• Strong knowledge of regulatory requirements (e.g., 21 CFR 820).
• Proven ability to lead cross‑functional teams and manage complex projects.
• Excellent analytical and problem‑solving skills.
• Effective communication and training delivery capabilities.

Required skills

• Process Failure Mode Effects Analysis (PFMEA)
• Quality Management System (QMS) implementation and maintenance
• Regulatory compliance (21 CFR 820 sections)
• CAPA management
• NCEP system administration

What we offer

• Opportunity to work with a global leader in medical technology.
• Access to advanced tools, training, and career development resources.
• Collaborative, high‑performance work environment.