QA Analyst - Medical Devices
About the Company
Our client are a leading organization in the healthcare technology and medical devices sector, committed to quality, innovation, and regulatory excellence. Operating across Ireland and the UK, we are driven by a mission to deliver safe, effective solutions while maintaining compliance with global standards.
About the Position
We are seeking a QA Analyst to support quality and compliance operations in Ireland and the UK. This role is critical in maintaining audit readiness, managing supplier quality, and ensuring compliance with ISO 13485:2016, EU MDR, and UK MDR standards. Working four days per week, you'll collaborate across departments to strengthen quality systems and operational controls.
Key Responsibilities
* Plan and execute internal, external, and corporate audits; maintain audit documentation.
* Conduct supplier evaluations and manage qualification checklists.
* Monitor and address non-conforming materials and quality issues.
* Support CAPA activities and change control documentation.
* Prepare and maintain SOPs and quality related documents.
* Assist in training initiatives related to compliance and quality systems.
* Provide operational quality support, including inspection processes and environmental monitoring.
Experience/Requirements
* Proven experience in quality assurance within medical devices or healthcare technology.
* Strong knowledge of ISO 13485:2016, EU MDR, EU MDD, and UK MDR.
* Certified Lead Auditor for ISO 13485 or equivalent.
* Experience in supplier management and regulatory compliance.
* Excellent documentation, audit, and communication skills.
* Ability to work independently and collaboratively across different regions.
Contact Melissa Caramante at or email with your CV to schedule a confidential discussion.