Quality Engineer III – Shift B

About the role

Boston Scientific is seeking a Quality Engineer III for Shift B to uphold patient safety and product quality. You will work within a high‑performing team, applying rigorous quality practices and supporting continuous improvement across manufacturing processes.

Key responsibilities

• Identify and resolve complex quality exceptions and non‑conforming material.
• Analyze test results, technical drawings, procedures and protocols to draw actionable conclusions.
• Lead investigations of customer complaints, document findings and generate analysis reports (GCS2).
• Drive corrective and preventive actions (CAPA, NCEP, Failure Mode investigations) and support root‑cause analysis.
• Evaluate new equipment, processes and chemicals for environmental impact and risk.
• Develop and review process validation protocols and reports.
• Provide training on GCS2 complaint‑handling software as needed.

Required profile

• Demonstrated commitment to the Quality Policy and patient safety.
• Strong knowledge of regulatory requirements governing quality systems (QSR, ISO/MDD, ISO 14971).
• Ability to ensure team members are trained and compliant with all relevant regulations.
• Independent authority to make product‑quality decisions.

Required skills

• QSR (21 CFR Part 820) and ISO 13485/ISO MDD standards.
• CAPA, NCEP and Failure Mode Investigation techniques.
• Risk Management per ISO 14971.
• Process validation methodology.
• Technical drawing interpretation.
• GCS2 complaint‑handling software.

What we offer

• Access to the latest tools, training and career development resources.
• Collaborative, diverse environment focused on high performance.