ISO Compliance Manager required to be responsible for implementing, maintaining and delivering quality and compliance.
You will have a technical, manufacturing or engineering background and experience in a quality or compliance role relating to standards in medical devices both in the UK and the EU. Ideally with high tech design and manufacturing.
ISO13485, MDD, MDR experience and understanding of medical devices is essential.
Role responsibilities
Maintaining ISO-9001 and ISO-13485 Quality Manuals, procedures and related documentation.
Understanding of the MDD and MDR regulations.
Liaison and management of Notified Body audits.
Management and data provision to provide customers with compliance certification relating to various international requirements such as Li-Po & Li-Ion battery compliance, RoHS, Conflict Minerals, TSA, FDA, CE, Certificates of Origin.
Management of internal records relating to compliance and quality throughout the design/production/manufacturing process.
