Description: An accredited company that manufactures medical devices for distribution in South Africa and internationally is looking for a Production Manager to join their team. The Production Manager will report to the CEO. The duties will include: Management of all production staff members including work planning, training, recruitment, disciplinary issues, performance appraisals and leave management. Responsible and accountable for execution and on time delivery on production orders. Development of expertise in all production processes. Responsibility and accountability for all production processes and products. Process Engineering and technical problem solving. Process Development and Process validation. IQ, OQ and PQ. Yield and Reject optimization. Production flow optimization. Management of the entire production environment which includes the clean room, non-clean room production facilities, raw material and consumable stock rooms. Work with Production logistics manager on production and materials planning (raw materials, consumables and finished product production planning). Handling of CAPA’s, Deviations and concessions and non-conformances in the Production department. Management of quality documentation relating to the Production Department. This will include writing of work instructions and related documents and ensuring correct documentation is used by Production staff at all times and that all staff is fully trained on the relevant work instructions. Facilitate and minute weekly production meetings. Participate in Management Meetings. Produce monthly and quarterly Production reports. Liaise with Quality Assurance and the Production/ Process Engineer to ensure product quality and efficient processes and efficient functioning of equipment. Ensuring that the Production department complies with ISO 13485 requirements at all times and is always audit ready. Participate as a member of the risk management team. Ensure the production department complies with the Occupational Health and Safety Act.
Key Requirements: Minimum BSc in engineering or related field. Minimum of five years’ experience in a relevant environment of which two must be at a management level. Experience working in a regulated environment is essential. Experience working in an ISO 13485 accredited environment will be advantageous as will previous experience working in or managing a clean room.
Additional Requirements: Analytical skills, technical problem solving skills, attention to detail, good eyesight to be able to work with microscopes and small products; meticulous record keeping.
Remuneration: Market related based on experience

Starting date: As soon as possible

*Only candidates that meet all the requirements should apply
**Please quote “Medical Device Production Manager (W368)” in the subject line
***Only candidates that are shortlisted will be contacted