QUALITY ENGINEER

Sem Matic Sdn Bhd; Johor Bahru; On-site; MYR 67,000 - 100,000; Full time

Job summary

Sem Matic Sdn Bhd is seeking a quality engineer to supervise in-process and final inspections, approve molded components, and lead CAPA for non-conformities in a medical device manufacturing environment.

You will document quality records, manage DHR/DMR updates, conduct root cause investigations, train inspectors, and support process validation and SPC initiatives, ensuring compliance with ISO 13485, FDA QSR, and GMP.

Qualifications

• Bachelor's degree in Engineering 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.

Responsibilities

• Supervise in-process inspection, final inspection, and product release activities.
• Monitor quality performance, implement CAPA for non-conformities.
• Conduct first article inspections (FAI) and oversee approval of molded components.
• Ensure accurate and timely completion of quality records, inspection reports, and batch documentation.
• Lead root cause investigations and document findings in quality reports.
• Supervise and train quality inspectors and technicians in inspection and quality control tasks.
• Conduct training on SOPs, GMP, GDP, and cleanroom behavior.
• Assign daily inspection tasks and verify completion and compliance.
• Support process validation (IQ/OQ/PQ) and statistical process control (SPC) initiatives.
• Monitor quality KPIs such as yield, scrap rate, and customer complaints.
• Handle customer complaint investigations and coordinate resolution.
• Review and approve supplier quality documents; participate in supplier audits and qualification.

Skills

Quality engineering

Inspection

CAPA

FAI

SPC

GMP knowledge

ISO 13485

Education

Bachelor's degree in Engineering

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.