Quality Engineer II

About the role

Boston Scientific is seeking a Quality Engineer II to provide process and quality engineering support across manufacturing sustaining, product transfer, and new product development teams. The role ensures delivery of the highest quality products to customers while supporting continuous improvement initiatives.

Key responsibilities

• Identify and disposition manufacturing process defects, including scrap, non‑conforming material, and customer complaints.
• Assist in root‑cause analysis and develop corrective and preventive actions (CAPA, NCEP, Failure Mode Investigations).
• Collaborate with process owners to define product stop boundaries and release criteria.
• Review product and quality specifications, and support quality system documentation.
• Execute and review process risk analyses; create and maintain risk files.
• Participate in equipment and process validation activities (IQ, OQ, PQ, TMVs) and approve related reports.
• Evaluate new equipment and processes, and support product transfer activities.
• Promote compliance with QSR, ISO/MDD, cGMP, and corporate SOPs.

Required profile

• Bachelor’s degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or a related field.
• English proficiency at B2 level (70‑79%).
• Experience with process and product validation is desired.

Required skills

• Process validation
• CAPA and NCEP management
• Failure Mode Investigation
• Equipment validation (IQ, OQ, PQ, TMVs)
• Quality System Regulation (QSR) knowledge
• ISO/MDD standards
• cGMP compliance
• Risk analysis and risk file creation
• SOP development and adherence