Supervisor, Quality Control

Supervisor, Quality Control

Cook Medical

Limerick, Ireland

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 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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