Quality Engineer – Product & Customer Quality

About the role

The Quality Engineer ensures that products, processes and systems meet customer, regulatory and company quality standards. You will lead improvement initiatives, investigate issues, and work closely with cross‑functional teams to drive operational excellence.

Key responsibilities

• Support and maintain the Quality Management System (QMS) in line with ISO 9001, ISO 14971 and GMP requirements.
• Lead CAPA investigations, root‑cause analysis and effectiveness verification.
• Plan and execute internal, supplier and customer audits, and assist with external regulatory audits.
• Participate in risk management activities, including hazard analysis and FMEA.
• Collaborate with R&D, manufacturing and regulatory affairs on new product development and process validation.
• Manage non‑conformance reports, product deviations and corrective actions.
• Drive supplier quality activities such as qualification, monitoring and performance evaluation.
• Analyze quality data, monitor metrics (PPM, FPY, scrap, complaints) and implement Lean/Six Sigma improvements.

Required profile

• Bachelor’s degree in engineering (Quality, Manufacturing, Mechanical, Industrial) or related field.
• 3–8 years of quality engineering experience in electronics, semiconductor, automotive, aerospace or similar high‑mix environments.
• Strong knowledge of ISO 9001, ISO 14971, GMP and quality tools.
• Proven experience with CAPA, audits, validation and document control.
• Excellent analytical, problem‑solving and communication abilities.

Required skills

• ISO 9001 Quality Management System
• ISO 14971 Risk Management
• Good Manufacturing Practices (GMP)
• FMEA and Control Plan development
• CAPA management
• Internal, supplier and customer audit execution
• Process validation and First Article Inspection (FAI)
• PPAP and APQP activities
• Statistical Process Control (SPC)
• Six Sigma methodology
• Root Cause Analysis
• Quality data analysis and metric monitoring