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 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.
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