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 the delivery of high‑quality products and drives continuous improvement.

Key responsibilities

• Identify manufacturing process defects, disposition non‑conforming material, and assist in root‑cause analysis.
• Work with process owners to define product stop boundaries and release criteria.
• Review product and quality specifications, and support quality systems documentation.
• Execute and review process risk analyses; create and maintain risk files.
• Participate in equipment and process validation activities, including IQ, OQ, PQ, and TMV reports.
• Support CAPA, NCEP, and failure mode investigations.
• Evaluate new equipment and processes, and assist in product transfer activities.
• Interpret technical drawings, procedures, and protocols; develop validation protocols and reports.
• Promote awareness of QSR, ISO/MDD, cGMP, and SOP standards in daily decision‑making.

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.
• Familiarity with quality systems, risk analysis, and regulatory standards (QSR, ISO, cGMP).

Required skills

• Process validation
• Product validation
• CAPA and NCEP investigation
• Failure mode investigation
• Equipment qualification (IQ, OQ, PQ, TMV)
• Technical drawing interpretation
• Risk analysis
• Knowledge of QSR, ISO/MDD standards, cGMP, SOPs