Overview
The primary purpose of this position is to lead a team of Quality Control Inspectors in a production environment.
Reporting to: Manager, Quality Control
Responsibilities
* 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 SOPs 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, CAPAs 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.
Qualifications
* 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.
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