The primary responsibility of this role is to provide Quality Assurance support. 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)
- 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.
- 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.