Our client is a leading Medical Device organisation. Due to continuous expansion, a new position for Senior Quality Supplier Engineer has arisen at their Co. Galway facility.
* Support the finished device manufacturing subcontractor and stent supplier to ensure that product quality and regulatory requirements are met.
* Support the operations group to ensure that product manufacture and release activities meet business needs.
* Review and contribute to process validation and risk management activities of the subcontractor and stent supplier.
* Provide manufacturing QA support to process and product development projects.
* Support operations, subcontractors and suppliers in implementing process improvement and lean initiatives.
* Ensure that SCAR's, CAPAs, NC's and other open action items, are completed in a thorough and timely manner.
* Assess and process supplier and changes, ensuring product impact is appropriately considered.
* Provide QA support for post product release supply chain activities, e.g. at storage facilities, distribution hub, distributors etc.
* Plan, execute, report and follow-up on subcontractor and supplier audits.
* Track and report progress across projects by reviewing schedules and due dates, identifying risks and assisting teams with contingency plans.
* Support the Complaint Coordinator in evaluation/investigation of product complaints.
* Support R&D and Design Assurance in development activities.
* A minimum of 5 years' relevant experience in the medical device industry, of which at least 4 years should be in a manufacturing quality role.
* Educated to a Minimum Diploma Level in an Engineering, Science or Quality Assurance discipline.
* Auditing Qualifications are desirable.
* Experience of managing relationships with subcontractors and suppliers is preferred.
* Experience in Class III medical device requirements, ISO 13485; 21 CFR 820; and MDD/MDR as well as Quality Management Systems.
* CAPA, Auditing and Risk Management experience per ISO 14971 (including FMECA).
* Attractive package on offer for the successful candidate
* Long-term career progression
To learn more about this role apply online or contact Anna Carey on 0873928655 for a confidential discussion.