Qa Analyst

2 weeks ago

Dublin, Dublin City, Ireland Brightwater Full time
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 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 , EU MDR, and UK MDR standards.
Working four days per week, youll collaborate across departments to strengthen quality systems and operational 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 , 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.
Skills: Quality Assurance Quality Control capa sop Auditing Internal Auditing

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