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
