Are you an experienced Quality Systems Engineer looking for a new role?
This is a fantastic opportunity to join a well-established manufacturing company who operate within the medical device industry based at their site in Cardiff.
Hours of work: Monday to Thursday 8:00am - 4:30pm, Friday 8:00am - 4:00pm
- Develop tools to ensure effectiveness of the quality management system ensuring compliance to applicable medical device standards and regulations.
- Document Control of the Quality Management System
- Support maintenance and improvement of the Quality Management system (QMS).
- Review changes for compliance with relevant standards, e.g. ISO13485 & ISO9001 and regulations, e.g. EU Medical Device Regulation, work with Process owners of the Standard Operating Procedures to ensure continued compliance.
- Review and align, where required, SOPs and associated forms, Instructions and Guides to relevant changes.
- Perform internal audits of the Quality Management Systems as determined by the QMS Internal Audit Schedule.
- Assist in External Audits and provide support to R&D.
The successful candidate:
- Previously worked in a QMS role within the Medical Device industry.
- Life Sciences Degree preferred but not essential.
- Knowledge of Quality Management standards to include: ISO13485:2016, ISO9001:2015 is essential
- Internal Auditing qualification would be preferred
- Knowledge of EU regulations to include: Medical Device Regulation 2017/745 & Directive 93/42/EEC is essential
- Competent in Microsoft Word and Excel
- Excellent written and verbal communication skills
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. Carbon60 is a trading name of Carbon60 Limited an Employment Business/Agency.
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