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Senior Quality Engineer

Our established and growing client is looking for an experienced Quality Engineer who is fully audit trained.

Responsibilities: 1.

To act as deputy for the site Quality Manager as-and-when required 2.

Supporting customers with their MDR submissions, reviewing, updating and maintaining both Design History Files and legacy Technical Files for compliance 3.

Ensuring Risk Management documentation (including pFMEAs) are up-to-date and in-line with the requirements of the current revision of ISO 14971 4.

Ownership of Quality Agreements, liaising with the Regulatory Department in order to compile and maintain 5.

Reviewing current QMS documentation for accuracy and relevance, updating or obsoleting as required 6.

Providing Quality support for projects (including forced material changes and new product development) 7.

Liaising with the site Quality Manager, Quality Engineers and / or Head of Quality (UK) to assist with product sterilization management 8.

Supporting the site Quality Manager with training, development and mentoring the site Quality Team 9.

Ad-hoc Quality-related tasks, as assigned by the site Quality Manager 10.

Supporting external audits and carrying out internal audits.


Root cause analysis for CAPA's and Non-conformances.

Essential Skills:


Problem solving and decision making 2.

Strong Project Management skills 3.

Excellent verbal, presentation and written communication skills.

Ability to communicate effectively at all levels of the organisation and to influence accordingly.


Team player with good interpersonal skills but also able to work on own initiative 5.

Good eye for detail 6.

Able to adopt a "can-do" attitude and influence this in others 7.

Excellent customer management skills 8.

Ability to work under pressure and to tight deadlines 9.

Always ready to challenge the status-quo and drive change

Essential Experience:


Qualified to degree level or equivalent in a relevant subject 2.

Minimum of 3 years experience in a Quality-focused role, within the health care industry 3.

Good working knowledge of Quality and Regulatory requirements for the manufacture and marketing of medical devices, to include experience of working with Design History Files and Technical Files 4.

Trained auditor

Due to location own transport is required.