Job Title: Distributed Products Compliance Lead
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Job Overview
We are seeking a seasoned Compliance Professional to oversee supplier management of 3rd party manufactured finished products, medical devices, and consumables; ensuring regulatory compliance and driving operational excellence within the 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).
Key Responsibilities:
* Implement and improve Supplier Quality processes ensuring Supplier Quality compliance to QMS and Supplier QMS for PDx, regulatory requirements, and overall process improvement
* Collaborate closely with Regional Quality, Suppliers, Sourcing, and Commercial Leaders, as well as the Supplier Quality Team to deliver improvements that minimize the Costs of Quality and Service, and factory defects
* Conduct reviews, perform audits, and document 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
* Ensure timely compliance with regulations and conformance with written, and approved procedures
* Manage Customer complaints related to 3rd party medical devices and accessories.
Requirements:
* 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 managing customer complaints.
Benefits:
* Competitive employee compensation package
* Pension contributions
* Health insurance
* Paid public holidays
Location: Ireland | remote