Our client, a new 'start up' medical device company based in Galway is seeking an ambitious and energetic individual for the following position with responsibility for the implementation and operation of the Company Quality Management System:
Quality Assurance Manager
Reporting to the Chief Executive Officer, this role is responsible for establishing the Company's quality assurance plan and ensures that the company operates under an approved Quality Management System that meets both regulatory and operational requirements. The Quality Manager plays a key role in developing the Company's strategy in determining and negotiating with regulatory bodies regarding its service offering to various customers.
Primary Responsibilities:
· Develop the Quality Management System (QMS) to FDA / CE compliance standards and interface with notified bodies to properly manage, plan and pass regulatory and quality audits to achieve and maintain the company's ISO 13485 certification.
· Advise R&D and Manufacturing on the regulatory impact of material selection, product design, manufacturing processes, product classification and the regulatory/product approval impact of specific customer product design revisions.
· Keep abreast of all new regulatory and quality guidelines and approval requirements for competitive technologies or "similar" risk products in the Company's area of focus and provide leadership on introducing technological advances and devices to Ireland.
· Interface with equivalent functions within our customer's organisations to ensure alignment regarding the quality and regulatory requirements of the various customer's products under development and/or manufacture.
· Engage with the Management Team on a regular basis to review the scope of the company's ISO certification and amend as required via the appropriate engagement with the relevant Notified Body.
The Successful Candidate will possess:
· An appropriate third level qualification with a minimum of 10 years' experience in the quality field at senior quality engineering or manager level having responsibility for CE market approval.
· Demonstrated ability for establishing and maintaining a Quality Management System having prepared for and passed quality inspections from a recognised Notified Body.
· Experienced project management skills and the ability to develop and execute a plan to achieve CE Mark.
· Risk management skills and experience in working with medical device engineers on how to set up and document the design and development process to ensure all work completed is documented and valid to support design and development and ultimately transfer to manufacture.
Benefits include a highly competitive remuneration package, including participation in the Company Share Option, Healthcare Insurance, Bonus and Pension scheme.
Applications please, or call for further information in strict confidence, by the 29
th
August 2025 to:
John Madden FCIPD Tel. No.:
* E-mail: or