A leading Medical Device company is currently seeking a Senior Supplier Quality Engineer for its Cork-based site.
Support the maintenance of an effective Supplier Quality System
Monitor Supplier performance per associated performance requirements
Liase on Suppliers quality issues and initiate/approve supplier corrective action Reports (SCARs) as required
Audit management - Support Supplier audit management and related records
Participate in Supplier Change Management and continuous improvement activities. Including associated change control documents and Validation/Qualification activities
Mitigate risk by working with the Supplier to document Process Flow Charts, PFMEAs, and Control Plans
Comply with regulatory requirements, Company policies, operating procedures, processes, and task assignments
Maintain positive and cooperative communications and collaboration with Supplier
Bachelor's Degree in a Quality, Science, or Food-related discipline.
3-5year relevant experience, at least 2yrs in a regulated manufacturing environment
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
Solid communication and interpersonal skills.
Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
For a confidential discussion and more information on the role, please contact Kevin Griffin.