Quality Assurance

6 days ago

Rayong, Rayong, Thailand The Siam Cement Public Company Limited Full time

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.

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