Senior Quality Engineer Position

Role – Senior Quality Engineer role
Location – Mildenhall, Suffolk
Working hours – Monday to Friday – Full time hours
Salary – £40,000 - £45,000 per annum
Capacity of role – Permanent position

Our client is a reputable and highly regarded company and they are currently recruiting for a Senior Quality Engineer. This role is a pivotal position where applicants will be able to make a difference within a quality bias position.
Main duties will include –
 Generating project documentation in line with ISO 13485 and other medical device regulatory requirements.
 Providing support with generating documentation relating to the manufacture of devices.
 Providing QA support for the implementation of ISO 13485:2016 and ISO9001: 2015
 Perform Tooling and manufacturing validation and equipment qualification for all products and processes
 Designated member of the complaints and feedback team with complaints handling responsibilities as described in relevant standard operating procedures
 Strong problem solving skills and techniques.
 Continuous improvement and a history of efficiency improvements
 To attend relevant training courses
 Maintenance and control of change activities
 Control of Maintenance and Calibration software
 Control of Approved Supplier List
 Carrying out Internal and External Audits against both ISO 13485 & ISO 9001 requirements
Candidate attributes –

 Good communication skills both written and verbally as you will be required documentation generating qualities, skills and cross-functional teamwork.
 Ideally you will required knowledge of Regulatory and QA systems.
 Will be confident to liaise with all departments within the business to ensure the smooth manufacturing process is withheld.
 You will be required to be disciplined, self motivated and be able to work as part of a team.
 Applicants must be comfortable with generating documentation and producing written updates so a working knowledge of Microsoft office programs is essential.