Overview
The primary purpose of this position is to lead a team of Manufacturing Operators with the support of team leads in a production environment. In addition, drive process/yield improvements to increase operational efficiency.
Reporting to: Manager, Production
Find out more about Cook Medical here
Responsibilities
- Responsible for raw material receipt, production & shipment of high quality medical devices within Cook Medical.
- Ensure that all COOK Quality system procedures and manufacturing procedures are adhered to in order to produce quality product.
- Ensure that output targets based on capacity plans are attained.
- Ensure that a high standard of compliance with GMP is maintained in the manufacturing areas.
- Ensure that changes to relevant procedures/instructions are relayed to those affected in production.
- Ensure that training needs of employees in the manufacturing area are constantly reviewed and that required training is given as appropriate.
- Ensure that all LMS training is up to date within the MBU.
- Monitor employee performance and carry out performance appraisals with employees.
- Maintain excellent communication channels with the production & distribution teams and with other departments through regular updates.
- Work closely with other functions to meet delivery requirements.
- Work on actions from assigned customer complaints, NCR’s, actions from internal/external audits and CAPA’s and determine root cause.
- Monitor non conformances and rework to ensure they are kept to a minimum.
- Highlight vendor issues, process issues, compliance issues to the relevant departments.
- Participate in Product Transfer and Product Development cross functional teams to ensure production readiness to implement new products into manufacturing, this will involve preparing/reviewing manufacturing instructions and Bills of Materials (BOM’s).
- Ensure adherence to all environmental, health & safety requirements in accordance with company policy.
- Act as delegate for Manager, Production as appropriate.
- Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
Qualifications
- Formal production/engineering qualification and/or relevant manufacturing experience (medical devices, plastics, etc.).
- Minimum 5 years previous experience in a supervisory position desirable.
- Strong communication and inter-personal skills.
- Knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
- Good computer skills including knowledge of Microsoft® Office.
- Excellent organisational and team building skills.
- High self-motivation.
- Willingness and availability to travel on company business.