Lead QA & Internal Auditor - Medical Devices

Cook Medical Inc.; Limerick; On-site; EUR 65,000 - 90,000; Full time

Job summary

Cook Medical Inc. in Limerick, Ireland, seeks a Quality Assurance professional to oversee the CMEU QMS and lead internal audits. You will ensure regulatory compliance and drive continuous improvement across regulatory audits and CAPA programs.

The role requires a Lead Auditor with strong knowledge of ISO13485, EU MDR and FDA QSR, plus excellent communication and travel willingness to support global quality activities.

Qualifications

• Experience with ISO13485, EU MDR 2017/745 and FDA QSR incl. 21 CFR Part 820/11.
• Lead Auditor certification preferred.
• Strong communication and organizational skills.
• Willingness to travel.
• Experience in medical device industry.

Responsibilities

• Maintain active oversight of the CMEU QMS to ensure it is fit for purpose and compliant with procedures and requirements.
• Act as Lead Internal Auditor with a team of Internal Auditors and maintain the internal audit system.
• Conduct in-depth internal audits and work with stakeholders to achieve QMS compliance.
• Maintain up-to-date knowledge of medical device regulations and requirements relevant to Quality Assurance.
• Organise site preparation and manage audit back rooms for regulatory and corporate audits.
• Lead QA process improvement initiatives and prepare key documentation.
• Support CAPA and Non-conformance programs and provide training on the CMEU Quality Manual.

Skills

Lead Auditor

ISO13485 knowledge

Regulatory knowledge

Quality Management System

Interpersonal skills

Communication skills

Travel willingness

Education

Third Level qualification in Quality, Science, Engineering or related

Tools

Microsoft Office

Job description

Cook Medical Inc. in Limerick, Ireland, seeks a Quality Assurance professional to oversee the CMEU QMS and lead internal audits. You will ensure regulatory compliance and drive continuous improvement across regulatory audits and CAPA programs.

The role requires a Lead Auditor with strong knowledge of ISO13485, EU MDR and FDA QSR, plus excellent communication and travel willingness to support global quality activities.