The primary purpose of this position is to lead a team of QC Manufacturing Team Members in a production environment.
Reporting to: Quality Control Manager
Find out more about Cook Medical here
- Responsible for Quality Control of medical devices within Cook Medical including inspection of raw materials, in-process product, finished and sterilized devices.
- Ensure that the work done by quality control personnel is in compliance with the requirements of the quality system.
- Prepare or review SOP’s manufacturing/quality control instructions, which are required by the quality team.
- Ensure that a high standard of cleanliness is maintained in the manufacturing areas in order to control product bio burden.
- Ensure that changes to relevant procedures/instructions are relayed to those affected in production.
- Ensure that training needs of employees in the QC area are constantly reviewed and that required training is given as appropriate.
- Monitor employee performance and carry out performance appraisals with employees.
- Maintain excellent communication channels with the production team and with other departments.
- Work closely with other departments to meet delivery requirements.
- Take ownership for assigned customer complaints, CAPA’s and determine root cause.
- Monitor rejects from quality control processes and disposition through MRB process
- Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
- Level 8 in Manufacturing Engineering or related discipline preferable.
- 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.
- Knowledge of Lean Manufacturing desirable
- 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.