Job Description
Overview: The primary responsibility of this role is to provide Quality Assurance support within Cook Medical Europe Ltd. (CMEU).
Responsibilities:
* Maintain an active oversight of the CMEU Quality Management System (QMS) to ensure it is fit for purpose and compliant with procedures, requirements, and best practice.
* Conduct internal audits of all aspects of the QMS against relevant regulations and collaborate with stakeholders to achieve zero non-conformances within CMEU.
* Maintain a detailed knowledge of medical device regulations, guidance, and requirements relevant to Quality Assurance.
* Organize and manage site preparation and 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 initiatives as appropriate.
Requirements:
* Third Level qualification in Quality, Science, Engineering, or other relevant technical discipline.
* Knowledge and experience in working with ISO 13485, ISO 14971, 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.
* Qualified and experienced Lead Auditor, preferably within the medical device industry.
* Good working knowledge of Microsoft Office.
* Strong interpersonal skills with the 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.