Distributed Products Compliance Lead
4 weeks ago
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 Track Wise is highly desirable.
CONSULTANT RESPONSIBILITIESImplement, and improve Supplier Quality processes ensuring Supplier Quality compliance to QMS and Supplier QMS for PDx, regulatory requirements and overall process improvementWork 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 defectsConducting reviews, performing audits and documenting findings for suppliersMake supplier pass/fail decisions based on evidence and established PDx proceduresProvide information and decision influence/guidance to PDx management as appropriate through escalationProviding follow up activities to ensure timely compliance with regulations and conformance with written, and approved proceduresManage Customer complaints related to 3rd party medical devices and accessories.
SKILLS/ QUALIFICATIONS NEEDEDBachelor or Master Degree in Biomedical Engineering or related fieldRelevant experience in the Medical Devices industry in a supplier quality roleExperience with the release of products and with implementing new productsExperience working with Sourcing, Commercial and with managing customer complaints.
LOCATION: REMOTE
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Distributed Products Compliance Lead
2 weeks ago
Cork, Cork, Ireland Oxford Global Resources Full timeSocial network you want to login/join with:Distributed Products Compliance Lead, Corkcol-narrow-leftClient:Oxford Global ResourcesLocation:Cork, IrelandJob Category:Other-EU work permit required:Yescol-narrow-rightJob Reference:fb6a91bc320cJob Views:11Posted:01.08.2025Expiry Date:15.09.2025col-wideJob Description:Job DescriptionJob DescriptionOur client is...
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