Lead Internal QA Auditor — Medical Device QMS Expert

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

Benefits offered by this job

Meaningful work

Competitive rewards

Hybrid/Remote options

Learning opportunities

Wellbeing programs

Job summary

Cook Medical Incorporated is seeking a Quality Assurance professional to oversee the CMEU QMS, lead internal audits, and drive CAPA initiatives. The role requires experience with ISO13485, EU MDR 2017/745, and FDA QSR, with lead auditor credentials preferred.

You will collaborate across departments, ensure regulatory compliance, and support training, KPI reporting, and management reviews. Travel on company business is expected.

Qualifications

• Requires 4+ years of experience with ISO13485, EU MDR 2017/745 and FDA QSR (21 CFR Part 820 & 11).
• Lead Auditor qualification preferred in medical device industry.
• Excellent communication across organisational levels.
• Strong organisational and analytical abilities.

Responsibilities

• Maintain CMEU QMS oversight and ensure compliance with procedures and best practice.
• Lead internal audits and manage a team of Internal Auditors.
• Conduct in-depth audits of QMS elements and drive CAPA improvements.
• Stay updated on medical device regulations and guidance.
• Prepare documentation for regulatory and corporate audits.
• Provide training on Quality Manual and key procedures.
• Support KPI reporting and Management Review presentations.

Skills

Quality assurance

Interpersonal skills

Attention to detail

Organisational skills

Travel willingness

Education

Third level qualification in Quality/Science/Engineering

Tools

Microsoft Office

Job description

Cook Medical Incorporated is seeking a Quality Assurance professional to oversee the CMEU QMS, lead internal audits, and drive CAPA initiatives. The role requires experience with ISO13485, EU MDR 2017/745, and FDA QSR, with lead auditor credentials preferred.

You will collaborate across departments, ensure regulatory compliance, and support training, KPI reporting, and management reviews. Travel on company business is expected.