Quality Assurance Specialist

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

Why You’ll Love Working at Cook

At Cook, we believe in taking care of our people so they can take care of others. As a global, family-owned company that has been improving patients' lives since 1963, we're committed to doing business with integrity and making a positive impact in the communities where we live and work.

Why You’ll Love Working at Cook

At Cook, we believe in taking care of our people so they can take care of others. As a global, family-owned company that has been improving patients' lives since 1963, we're committed to doing business with integrity and making a positive impact in the communities where we live and work. We're guided by strong ethical standards and core values, and we believe the best ideas come from creating solutions together. Our company culture values every voice, brings together inclusive teams who collaborate well, and encourages learning and innovation. When you join Cook, you're not just starting a job, you're building a career with purpose, in a company that invests in you.

What You Can Expect At Cook

These are some ways we support our people across Cook:

• Meaningful work & strong values: Contribute to improving patient care globally in a company known for high ethical standards and integrity.
• Competitive rewards & security: Competitive, performance-related compensation and benefits that support your health and financial wellbeing.
• Flexibility & time off: Paid time off, holidays, and hybrid or remote work options for many jobs, where possible.
• Growth & development: Learning opportunities, educational assistance, and development programs to help you grow your skills and career.
• Wellbeing & community: Health and wellness initiatives, social activities, and community engagement that help you feel connected and supported.

Benefits and programs vary by country and job. Our recruiters can provide more information about the specific benefits and programs available in your location.

Overview

The primary responsibility of this role is to provide Quality Assurance support as required within Cook Medical Europe Ltd. (CMEU). This includes completing internal audits and maintaining the internal audit system; providing support to software validation, change requests, non-conformance issues and the Company's corrective and preventive action program; and assisting in the implementation and improvement of all aspects of the quality management system (QMS).

Responsibilities

• Maintain an active oversight of the CMEU QMS to ensure it is fit for purpose and ensures compliance with procedures, requirements and best practice.
• Maintain the internal audit system in CMEU, acting as Lead Internal Auditor with a team of Internal Auditors.
• Conduct in-depth internal audits of all aspects of the QMS against the relevant regulations, and work collaboratively with relevant stakeholders to achieve QMS compliance.
• Maintain a detailed and up to date knowledge of medical device regulations, guidance and requirements relevant to Quality Assurance.
• Organise site preparation and manage audit back rooms for Regulatory and Corporate Audits.
• Identify, lead and drive QA process improvement initiatives as appropriate.
• Prepare, review and maintain key Quality Systems related documentation.
• Maintain and support the Corrective and Preventive Action (CAPA) program.
• Maintain and support the Non-conformance program.
• Delegate for the Manager, Quality Assurance, CMEU.
• Provide training on the CMEU Quality Manual and other key Quality Systems procedures as required.
• Provide input to KPIs and Management Review. Prepare Management Review presentations as appropriate.
• Provide meaningful Quality Assurance measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
• Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.

Qualifications

• Third Level qualification in Quality, Science, Engineering or other relevant technical discipline.
• Proven knowledge and experience (min 4 years) of working with ISO13485, the Medical Device Directive, EU Medical Device Regulation 2017/745 and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, all ideally gained in the medical device industry.
• Qualified and experienced Lead Auditor, preferably within the medical device industry.
• Good working knowledge of Microsoft Office.
• Strong interpersonal skills with the proven ability to communicate effectively at all organisational levels.
• Ability to challenge / influence thinking / opinion / actions with the aim of ensuring CMEU QMS is adhered to.
• High attention to detail.
• Excellent organisational skills, with the ability to manage own time effectively.
• High self-motivation, with a proactive, solution driven approach to problem-solving.
• Willingness and availability to travel on company business.