A Quality Supervisor

5 days ago

Masai, Malaysia SUPER HERO FAMILY ENTERPRISE Full time

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

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