ISO Compliance Manager
The ISO Compliance Manager is responsible for implementing, maintaining, and delivering quality and compliance in medical device manufacturing. The role requires a background in technical, manufacturing, or engineering fields, with experience in quality or compliance related to standards in medical devices within the UK and EU.
Key responsibilities include:
1. Maintaining ISO-9001 and ISO-13485 Quality Manuals, procedures, and related documentation.
2. Understanding and ensuring compliance with MDD and MDR regulations.
3. Managing liaison and coordination of Notified Body audits.
4. Providing management and data to support compliance certification for international standards such as Li-Po & Li-Ion batteries, RoHS, Conflict Minerals, TSA, FDA, CE, and Certificates of Origin.
5. Managing internal records related to compliance and quality throughout the design, production, and manufacturing processes.
Experience with high-tech design and manufacturing is preferred, along with expertise in ISO13485, MDD, MDR, and medical device regulations.
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