QA Supervisor
1 week ago
**Responsibilities**:
**1. Production Quality Oversight**
- Supervise in-process inspection, final inspection, and product release activities.
- Monitor shop floor quality performance and implement corrective and preventive actions (CAPA) for non-conformities.
- Conduct First Article Inspections (FAI) and approve 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.
- 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 practices.
- 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 and analyze quality KPIs such as yield, scrap rate, and customer complaints.
**5. Customer & Supplier Interface**
- Handle customer complaint investigations and coordinate resolutions.
- 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 of QA/QC experience in manufacturing, preferably in 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 in-process inspection, final inspection, and First Article Inspection (FAI).
- Strong problem-solving skills, including root cause analysis (CAPA, 8D reports) and SPC.
Pay: RM5,500.00 - RM8,000.00 per month
Application Question(s):
- Have you worked in a clean-room-controlled production environment before?
Work Location: In person
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