Quality Assurance (Automated Medical Device) - VEM-TH, SCGP (Rayong-based)

Job Description

• Develop, implement, and monitor quality control procedures for automated assembly of medical devices.

• Conduct root cause analysis (RCA) and corrective/preventive actions (CAPA) for non-conformances and process deviations.

• Collaborate with cross-functional teams (engineering, production, regulatory) to ensure compliance with ISO 13485.

• Perform statistical process control (SPC), measurement system analysis (MSA), and capability studies on critical process parameters.

• Lead validation activities, including IQ/OQ/PQ for new equipment and process changes.

• Support internal and external audits, including FDA, Notified Body, and customer inspections.

• Analyze quality trends and implement data-driven improvements to reduce scrap, rework, and downtime.

• Maintain and improve documentation systems, including SOPs, work Instructions, and inspection protocols.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Industrial, Quality Engineering, or related fields.

• Over 5 years of experience in quality engineering within automated, high-volume medical device manufacturing.

• Strong understanding of GMP, ISO 13485, and FDA QSR requirements.

• Proficiency in quality tools such as FMEA, 8D, DOE, SPC

• Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt.

• Familiarity with cleanroom protocols and sterile barrier systems.

• Experience with automated inspection systems, vision systems, and digital quality platforms.

• Excellent analytical, documentation, and communication skills.

• Good command of English - able to report to foreign managers.