Senior Quality Assurance Manager
5 days ago
Job Summary:
We are seeking a highly skilled and experienced Senior Quality Assurance Manager to lead our team of Quality Control Inspectors in a production environment.
Main Responsibilities:
- Ensure Quality Control of medical devices within Cook Medical, including inspection of raw materials, in-process product, finished and sterilized devices.
- Develop and implement quality control procedures to ensure compliance with regulatory requirements.
- Maintain excellent communication channels with the production team and 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.
Requirements:
- 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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