MEDIC QA ENGINEER

Sem Matic Sdn Bhd; Johor Bahru; On-site; MYR 60,000 - 90,000; Full time

Job summary

Sem Matic Sdn Bhd is seeking a Quality Engineer to supervise in-process and final inspections, drive CAPA actions, and oversee FAI and molded component approvals.

The role emphasizes documentation (DHR/DMR), root cause investigations, and training for inspectors. It also supports process validation (IQ/OQ/PQ) and SPC, with a focus on ISO 13485, GMP and FDA QSR compliance.

Qualifications

• Degree in Engineering or related field required.
• 3–5 years of quality engineering experience in medical devices or precision manufacturing preferred.
• Experience with ISO 13485 is mandatory.
• Knowledge of 21 CFR Part 820 and GMP practices.
• Familiar with plastic injection molding and inspection techniques.

Responsibilities

• Supervise inspection activities for in-process, final, and product release.
• Monitor quality performance and implement CAPA for non-conformities.
• Conduct FAI and oversee approval of molded components.

Skills

Quality engineering

Inspection techniques

CAPA leadership

SPC

Documentation

Education

Bachelor's degree in Engineering

Tools

ISO 13485

FDA QSR (21 CFR Part 820)

GMP knowledge

Plastic injection molding

Job description

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

Monitor quality performance, 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.

Qualification Requirement:

• Degree in Engineering (Mechanical, Manufacturing, Biomedical, or related field).
• 3–5 years experience in quality engineering, preferably in medical device manufacturing or precision machining.
• Experience with ISO 13485 is mandatory.
• Knowledge of 21 CFR Part 820 (FDA QSR), and Good Manufacturing Practices (GMP).
• Familiar with plastic injection molding process and inspection techniques.