QARA Specialist

Cure Talent is delighted to partner with a market leading Medical Device company who specialise in emergency medical products. Due to their ongoing growth, we have an exciting opportunity for a QARA Specialist to join their team in County Wicklow, Ireland.

We are looking for an experienced Quality Assurance professional from a Medical Device background who has experience within a ISO13485 QMS. You will have experience of QMS Management, CAPA, NCR, Risk Management and auditing.

As the new QARA Specialist, you will be responsible for all things Quality Assurance, working closely with external teams to foster a culture of compliance. Your role will involve overseeing the maintenance and development of the QMS, providing support for Corrective and Preventative Actions (CAPAs), Non-Conformance Reports, conducting audits, and managing risk.

Key responsibilities

• Maintaining and developing the ISO 13485 QMS
• Manage the PMS, CAPA and NCR processes
• RCA, Deviations, FSCA, Change Controls, Technical Documentation, Labelling, Risk Management
• Participate in internal and external audits
• Support Regulatory Affairs with Product Submissions

The ideal candidate will have the following skills and experience:

• Proven experience in a Quality Assurance Role within a Medical Device Environment
• Proven experience of maintaining, developing and/or implementing an ISO 13485 QMS
• Experience of CAPAs, NCRs, RCA, PMS, FSCA & Technical Documentation
• Auditing experience
• EUMDR & ISO 14791 knowledge is highly advantageous

If this feels like the right role for you and you would like to join an award-winning organisation that contributes to saving lives across the globe, please get in touch or apply today!