- Plan, coordinate, and monitor day-to-day production activities to ensure smooth workflow and timely delivery.
- Optimize production processes to achieve maximum efficiency and quality.
- Ensure production output meets required quality standards and ISO 13485 compliance.
- Collaborate with cross-functional teams (Quality, Maintenance, and Supply Chain) to resolve production issues.
- Prepare and maintain production records, reports, and documentation in line with QMS and regulatory requirements.
- Support process validation, equipment qualification, and continuous improvement initiatives.
- Assist in the implementation of Lean Manufacturing and 5S principles on the shop floor.
- Train and supervise operators and technicians in standard work procedures and safety protocols.
- Monitor equipment performance and coordinate preventive maintenance activities.
- Contribute to CAPA actions related to production processes.
Qualifications & Experience:
- Diploma or Bachelor's in Mechanical, Production Engineering, or related field.
- 1–2 years of experience in a production/manufacturing environment, preferably in medical devices or pharmaceutical industry.
- Hands-on experience with ISO 13485 certified systems is mandatory.
- Familiarity with medical device regulations is an advantage.