Quality Engineer

The Quality Engineer II is responsible for ensuring product quality, process compliance, and effective execution of Quality Management System (QMS) requirements throughout the product lifecycle. This role partners with Manufacturing, Engineering, R&D, Regulatory Affairs, Quality Control, and Supply Chain teams to investigate quality issues, execute CAPAs, support risk management activities, maintain regulatory compliance, and drive continuous improvement initiatives. The position requires strong analytical skills, root cause investigation experience, and knowledge of regulated manufacturing environments such as medical devices, biotechnology, diagnostics, or pharmaceuticals.

• Investigate nonconformances, deviations, and quality issues.
• Lead CAPA activities and root cause investigations using tools such as 8D, Fishbone, and 5-Why.
• Conduct risk assessments (DFMEA, PFMEA, ISO 14971).
• Support New Product Introduction (NPI), design control, validation, and change control processes.
• Analyze quality metrics and manufacturing data to identify trends and improvement opportunities.
• Support complaint investigations, audits, and regulatory inspections.
• Ensure compliance with FDA, GMP, ISO 13485, and QMS requirements.
• Drive continuous improvement initiatives using Lean and Six Sigma methodologies.