Quality and Compliance Engineer

Contract Personnel are currently recruiting for a Quality and Compliance Engineer to join their team on the outskirts of Mildenhall. 

Our client is a leader within their field, due to continued growth, they are now seeking to add an experienced Engineer who can maintain and support the implantation of quality standards within their team.
You will be responsible for writing and executing documentation to ensure the business excels within this area.

Candidate will be required to be disciplined, possess self-discipline and self-motivation to work as part of a team and to work alone.

Main duties will include –

• To provide support with generating documentation relating to their product range.
• Generating documentation in line with ISO 13485 and other regulatory requirements.
• Providing QA/RA support for the implementation of ISO 13485:2016, ISO9001: 2015, MDR and FDA.
• Dealing with suppliers, ensure compliance with company policies, periodic auditing and completing Risk management around the Approved Supplier List (ASL).
• Management and Control of Master Document List (MDL)
• Change Control (ECR), Corrective and Preventative (CAPA)
• Strong problem solving skills and techniques.
• Continuous improvement and a history of efficiency improvements
• To attend relevant training courses
• Methodical, logical and attention to detail skills

Candidate attributes –

• Minimum qualification for internal auditing to ISO9001:2015 and/or ISO13485:2016
• Industry experience within the medical sector.
• Strong project leadership skills (six sigma)
• Understanding of Clean-room operation, environmental control and monitoring plan (EMP)
• Keeping training records and matrices up to date
• External Audit experience
• Control of Standards implementation of projects of varying size and impact across a diverse set of medical devices.
• This will require knowledge of Regulatory and QA systems as well as good communication skills (verbal and written).
• This individual will be required to interact closely with other medical and non-medical team members, as well as cross-functional partners such as Marketing, Supply Chain, Engineering, and Sales.

For more detail on this exciting opportunity, please contact Gemma Ellis on 01842 750222 or 07387108410 or gellis@cpl.uk.com