Senior Engineer, Product Quality

About the role

The Senior Engineer, Product Quality will ensure continuous compliance with GMP and regulatory requirements, lead non‑conformance handling, and drive quality improvements across product transfer, production, and monitoring.

Key responsibilities

• Stop further processing of non‑conforming products and lead customer complaint handling.
• Implement Stryker corporate quality policies, ensuring GMP and ISO compliance.
• Maintain and monitor processes for product transfer, production, and quality inspection, including inspection guides and equipment management.
• Define, approve, and apply standards, methods, and procedures for product testing and evaluation.
• Develop, modify, and execute regulatory‑related quality guidelines and procedures.
• Train staff on GMP, ISO, Quality Assurance, and Regulatory Affairs topics.
• Participate in internal quality and regulatory audits and communicate results.
• Lead Lean initiatives to standardize processes and eliminate waste.
• Authorize product release or rejection according to quality system requirements.
• Own and report supplier‑related quality issues, participate in supplier change reviews, and act as contact during audits.

Required profile

• More than 5 years of experience in Quality Assurance or related functional area.
• Experience with GMP or ISO quality systems.
• College/B.S. degree in engineering or a related discipline.

Required skills

• Familiarity with PPAP, FMEA, MSA, process control plans, and SPC.
• Ability to analyze and resolve non‑routine product issues independently.
• Strong logical thinking and effective problem‑solving skills.
• Good communication and training abilities.
• Basic PC skills with proficient Excel operation.