Social network you want to login/join with:
Distributed Products Compliance Lead, Cork
col-narrow-left
Client:
Oxford Global Resources
Location:
Cork, Ireland
Job Category:
Other
-
EU work permit required:
Yes
col-narrow-right
Job Reference:
fb6a91bc320c
Job Views:
11
Posted:
01.08.2025
Expiry Date:
15.09.2025
col-wide
Job Description:
Job Description
Job Description
Our client is seeking 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.
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
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.
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 with managing customer complaints.
Benefits
Competitive and attractive employee compensation package
Pension contributions
Health insurance
Paid public holidays
Location:
Ireland | remote
#J-18808-Ljbffr