Production Supervisor

Pentamaster Corporation Berhad (Official); Penang; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading medical device manufacturer in Malaysia seeks a detail-oriented Production Supervisor to oversee daily manufacturing operations. This role is essential for ensuring compliance with ISO 13485 in the production of intravenous catheters and pen needles. The successful candidate will manage production activities, documentation, and staff training to maintain high quality and safety standards.

Qualifications

• Experience in a medical device or regulated manufacturing environment preferred.
• Proven experience in creating SOPs and WIs in a GMP-compliant setting.
• Strong understanding of ISO 13485 and FDA 21 CFR Part 820.

Responsibilities

• Supervise daily production activities ensuring targets and quality standards are met.
• Develop, review, and maintain SOPs and production documentation for ISO 13485 compliance.
• Train production staff on SOPs and WIs.

Skills

Leadership

Interpersonal Skills

Team Coordination

Communication Skills

Education

Diploma or Degree in Engineering, Life Sciences, Manufacturing

Job description

Job Summary:

We are seeking a detail-oriented and experienced Production Supervisor to oversee daily operations on the manufacturing floor, with a strong emphasis on documentation and compliance. This role is critical in ensuring production processes and documentation (SOPs, WIs, DHRs, etc.) meet ISO 13485 requirements for the manufacture of intravenous catheters (IVCs) and pen needles.

Key Responsibilities:

1. Supervise daily production activities, ensuring targets, quality, and safety standards are met.
2. Develop, review, and maintain Standard Operating Procedures (SOPs), Work Instructions (WIs), and production documentation in alignment with ISO 13485.
3. Coordinate with Quality Assurance, Validation, and Engineering departments for document control and approval workflows.
4. Train production staff on SOPs and WIs, ensuring adherence to documented procedures.
5. Maintain accurate Device History Records (DHRs) and Batch Records in compliance with traceability requirements.

Required Skills & Qualifications:

1. Diploma or Degree in Engineering, Life Sciences, Manufacturing, or equivalent.
2. Experience in a medical device or regulated manufacturing environment, preferably with ISO 13485. (Advantage)
3. Proven experience in creating and maintaining SOPs and WIs in a GMP-compliant setting.
4. Strong understanding of ISO 13485, FDA 21 CFR Part 820, and good documentation practices (GDP). (Advantage)
5. Good leadership, interpersonal, and team coordination skills.
6. Excellent written and verbal communication skills in English.