Job Description:
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As a Distributed Products Compliance Leader, you will oversee the supplier management of third-party manufactured finished products, medical devices, and consumables. Your role is to ensure regulatory compliance and drive operational excellence within our Pharmaceutical Diagnostics division.
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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.
Responsibilities:
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1. Implement and improve Supplier Quality processes ensuring Supplier Quality compliance to QMS and Supplier QMS for PDx, regulatory requirements, and overall process improvement.
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2. 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.
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3. Conducting reviews, performing audits, and documenting findings for suppliers.
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4. Make supplier pass/fail decisions based on evidence and established PDx procedures.
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5. Provide information and decision influence/guidance to PDx management as appropriate through escalation.
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6. Providing follow-up activities to ensure timely compliance with regulations and conformance with written, and approved procedures.
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7. Manage Customer complaints related to 3rd party medical devices and accessories.
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8. SKILLS/QUALIFICATIONS NEEDED:
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9. Bachelor or Master Degree in Biomedical Engineering or related field.
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10. Relevant experience in the Medical Devices industry in a supplier quality role.
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11. Experience with the release of products and with implementing new products.
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12. Experience working with Sourcing, Commercial, and managing customer complaints.
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13. LOCATION: REMOTE
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