QA Engineer (Medical Devices Manufacturing)

Key Responsibilities

Ensure compliance with ISO 13485, GMP, FDA 21 CFR Part 820, and company Quality Management System (QMS).

Monitor manufacturing processes to ensure product quality meets customer and regulatory requirements.

Lead investigations on product non-conformances, customer complaints, and manufacturing deviations.

Coordinate and monitor Corrective and Preventive Actions (CAPA).

Review and approve quality documents including SOPs, work instructions, inspection standards, validation protocols, and engineering change documentation.

Support internal, supplier, and external audits, including customer and regulatory inspections.

Analyze quality data, identify trends, and recommend process improvements.

Participate in risk management activities and process validation.

Work closely with Production, Engineering, R&D, Supply Chain, and Manufacturing teams to resolve quality issues.

Support New Product Introduction (NPI) by ensuring quality requirements are incorporated into manufacturing processes.

Ensure calibration, inspection, and testing activities are performed according to established procedures.

Prepare quality reports, KPIs, and documentation for management review.

Train employees on quality procedures, regulatory requirements, and good documentation practices (GDP).

Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.

Job Requirements

Bachelor's Degree in Engineering or related disciplines

Minimum 2–5 years of Quality Assurance experience in a manufacturing environment.

Experience in medical device, healthcare, pharmaceutical, electronics, or other regulated industries is highly preferred.

Experience handling customer audits and regulatory compliance is an advantage.

Pay: RM3,000.00 - RM6,000.00 per month

Benefits:

Opportunities for promotion

Professional development

Work Location: In person