Cathx Site Quality Lead
About The Position
Ensure the effectiveness and continuous improvement of the manufacturing site to ensure customer satisfaction and achieve the quality policy objectives. Provide daily oversight to the Quality staff at the manufacturing site with the exception of the Design assurance engineers. Ensure compliance with 21CFR820, ISO 13485, and EU MDR 2017/745 (the requirements) as applicable to CathX at the manufacturing site. Oversee the following activities at the site for on-time completion and compliance with requirements: Inspection, measuring and testing Nonconforming materials Complaints and RMA Corrective and preventive action Gemba walks and LPA Equipment and process validation Facility maintenance Environmental monitoring and testing
Responsibilities
- Ensure the effectiveness and continuous improvement of the manufacturing site
- Provide daily oversight to the Quality staff at the manufacturing site
- Ensure compliance with 21CFR820, ISO 13485, and EU MDR 2017/745
- Oversee inspection, measuring and testing
- Oversee nonconforming materials
- Oversee complaints and RMA
- Oversee corrective and preventive action
- Oversee Gemba walks and LPA
- Oversee equipment and process validation
- Oversee facility maintenance
- Oversee environmental monitoring and testing
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What This Job Offers
Industry
Plastics and Rubber Products Manufacturing
Education Level
No Education Listed
Number of Employees
1,001-5,000 employees
