-
Job Description
Quality Assurance Specialist sought to maintain and improve the Quality Management System (QMS) within Cook Medical Europe Ltd, ensuring compliance with regulations and best practices.
Key responsibilities include:
- Maintaining an active oversight of the CMEU QMS to ensure it is fit for purpose and ensures compliance with procedures, requirements and best practice.
- Maintaining the internal audit system in CMEU, acting as the Quality Internal Auditor with a team of Internal Auditors.
- Conducting in-depth internal audits of all aspects of the QMS against the relevant regulations, and working collaboratively with relevant stakeholders to achieve zero non-conformances within CMEU.
- Maintaining a detailed and up-to-date knowledge of medical device regulations, guidance and requirements relevant to Quality Assurance.
- Organising and managing site preparation and managing audit back rooms for Regulatory and Corporate Audits.
- Providing Quality Assurance support to all areas of the QMS, ensuring compliance is maintained at all times.
- Identifying, leading and driving QA process improvement initiatives as appropriate.
- Preparing, implementing and analysing key Quality Systems related documentation.
- Maintaining and supporting the Corrective and Preventive Action (CAPA) program.
- Maintaining and supporting the Non-conformance program.
- Providing training on the CMEU Quality Manual and other key Quality Systems procedures as required.
- Providing inputs to KPI's and Management Review.
- Preparing Management Review presentations as appropriate.
- Providing meaningful Quality Assurance measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
- Ensuring that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.
Requirements:
- 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).
- 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.