Quality Systems Engineer
- Recruiter
- Confidential
- Location
-
Cardiff
Cardiff (Caerdydd)United Kingdom
- Salary
- Competitive
- Posted
- 07 Jul 2021
- Closes
- 04 Aug 2021
- Job Title
- IT Director
- Category
- Professional Services
- Contract Type
- Permanent
- Hours
- Full Time
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.
Salary: Negotiable
Location: Cardiff
Hours of work: Monday to Thursday 8:00am – 4:30pm, Friday 8:00am – 4:00pm
The role:
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 skillsThe 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
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.
Salary: Negotiable
Location: Cardiff
Hours of work: Monday to Thursday 8:00am – 4:30pm, Friday 8:00am – 4:00pm
The role:
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 skillsThe 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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