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.
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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Cook Medical is proud to be an equal opportunity employer and we know that diversity makes us stronger and better as a company. Every day we make life-saving products and do what is best for patients worldwide, and the people that join Cook make this possible. In keeping with our Cook Group values, we are committed to treating all employees equally regardless of gender, civil status, family status, sexual orientation, religious belief, age, disability, race or membership of the traveller community. It is our policy to ensure that as much accommodation as possible is carried out to facilitate the participation of all individuals to ensure equity in the recruitment process and in the workplace
