Senior Process Quality Manager

About the role

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

Key responsibilities

• Coordinate activities of Quality Engineering and In‑Process Quality Engineering teams, supporting new product and process transfers.
• Design, implement and monitor process control strategies, including PFMEA reviews and in‑process defect prevention projects.
• Maintain and improve Quality Management System chapters such as production controls, process validation, traceability, CAPA, and non‑conforming product handling.
• Act as subject‑matter expert for regulatory sections (e.g., 820.70, 820.75, 820.100) and serve as an authorized signatory in the Quality Director’s absence.
• Provide technical training, create or update procedures, and manage NCEP investigations and MRB activities.

Required profile

• University degree in Industrial, Electronic, Biotechnology, Electromechanical Engineering or a related field.
• Minimum 7 years of experience in a similar quality management role, including people‑management responsibilities.
• Proven experience with medical device regulations (MDR/MDV) and complaint handling.

Required skills

• Formal training in statistical and quality techniques.
• Knowledge of Six Sigma, Lean, and APQP tools.
• Familiarity with MDR and MDV regulatory requirements.