QA Supervisor

2 days ago

Ulu Tiram, Johor, Malaysia Agensi Pekerjaan Alpha Alliance Sdn Bhd Full time 80,000 - 120,000 per year

Job 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.

Job Type: Full-time

Pay: RM5, RM8,000.00 per month

Benefits:

  • Opportunities for promotion
  • Professional development

Application Question(s):

  • Have you worked in a clean-room-controlled production environment before?

Work Location: In person

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