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A dynamic and experienced compliance Leader to oversee supplier management of 3rd party manufactured finished products, medical devices, and consumables; to ensure regulatory compliance, and to drive operational excellence within their Pharmaceutical diagnostics division.
The ideal candidate will have a strong background in medical devices and supplier auditing with additional knowledge of pharmaceuticals and regulatory frameworks (EU MDR, FDA, MDSAP). Experience with digital tools such as TrackWise is highly desirable.
CONSULTANT RESPONSIBILITIES
- Implement, and improve Supplier Quality processes ensuring Supplier Quality compliance to QMS and Supplier QMS for PDx, regulatory requirements and overall process improvement
- Work closely with Regional Quality, Suppliers, Sourcing and Commercial Leaders, and Supplier Quality Team to deliver improvements that minimize the Costs of Quality and Service, and factory defects
- Conducting reviews, performing audits and documenting findings for suppliers
- Make supplier pass/fail decisions based on evidence and established PDx procedures
- Provide information and decision influence/guidance to PDx management as appropriate through escalation
- Providing follow up activities to ensure timely compliance with regulations and conformance with written, and approved procedures
- Manage Customer complaints related to 3rd party medical devices and accessories.
SKILLS/ QUALIFICATIONS NEEDED
- Bachelor or Master Degree in Biomedical Engineering or related field
- Relevant experience in the Medical Devices industry in a supplier quality role
- Experience with the release of products and with implementing new products
- Experience working with Sourcing, Commercial and with managing customer complaints.
LOCATION: REMOTE
