Job Description

:

1. Production Quality Oversight

? Supervise in-process inspection, final inspection, and product release activities.

? Monitor quality performance on the shop floor; implement corrective and preventive actions (CAPA) for non-conformities.

? Conduct first article inspections (FAI) and oversee approval of molded components.

2. Documentation & Reporting

? Ensure accurate and timely completion of quality records, inspection reports, and batch documentation.

? Maintain device history records (DHR) and support device master record (DMR) updates as needed.

? Lead root cause investigations and document findings in quality reports.

3. Team Management & Training

? Supervise and train quality inspectors and technicians to ensure competency in inspection and quality control tasks.

? Conduct training on SOPs, GMP, GDP, and cleanroom behavior as needed.

? Assign daily inspection tasks and verify completion and compliance.

4. Continuous Improvement & Risk Management

? Support process validation (IQ/OQ/PQ) and statistical process control (SPC) initiatives..

? Monitor quality KPIs such as yield, scrap rate, and customer complaints.

5. Customer and Supplier Interface

? Handle customer complaint investigations and coordinate resolution.

? Review and approve supplier quality documents; participate in supplier audits and qualification.

Job Requirements:

? Degree in Quality Management, Mechanical Engineering, or related field

? Minimum 2-4 years working experience in manufacturing QA/QC, preferably with injection molding or medical device production

? Knowledge of ISO 13485, GMP, GDP, and quality inspection standards

? Ability to supervise and train inspectors and technicians on SOPs and inspection procedures

? Experience in managing in-process inspection, final inspection, and first article inspection (FAI)

? Skilled in problem solving and root cause analysis (e.g., CAPA, 8D reports, SPC)

Job Type: Permanent

Pay: RM6,000.00 - RM8,000.00 per month

Benefits:

Professional development
Work Location: In person