Quality Assurance Specialist 2

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)

Reporting to: Senior Manager, Quality Assurance

Find out more about Cook Medical here

• 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 the Quality 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 zero non-conformances within CMEU.
• Maintain a detailed and up to date knowledge of medical device regulations, guidance and requirements relevant to Quality Assurance.
• Organise and manage site preparation and manage audit back rooms for Regulatory and Corporate Audits.
• Provide Quality Assurance support to all areas of the QMS, ensuring compliance is maintained at all times.
• Identify, lead and drive QA process improvement initiative as appropriate.
• Prepare, implement and analyse key Quality Systems related documentation.
• Maintain and support to 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 inputs to KPI’s 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.

• Third Level qualification in Quality, Science, Engineering or other relevant technical discipline.
• Knowledge and experience (min 4 years of working with ISO13485, ISO14971, the Medical Device Directive , the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, Regulation (EU) 2017/745 (EU MDR) and other Regulations applicable to EMEA regions, ideally gained in the medical device industry, desirable.
• Qualified and experienced Lead Auditor, preferably within the medical device industry.
• Good working knowledge of Microsoft Office, desirable.
• Strong interpersonal skills with the proven ability to communicate effectively at all organisational levels.
• Demonstrable 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 if required