Connecting Talent to opportunity

Connecting Talent to opportunity

Quality Engineer – Medical Devices

Expired

Job Description:

Quality Engineer

Farnborough

£40,000 – £50,000

Austin Vita are recruiting for a Quality Engineer to join a global organisation at the forefront of their industry. This company is already recognised as a market leader and has exciting plans for continued growth. As well as their innovation and success being a clear attraction to join the business, they also have a fantastic working culture and pride themselves on the opportunities they provide their people.

As a Quality Engineer you are responsible for driving CAPA Review Board activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content Representing CAPAs during audits, CAPA Review Board meetings and the main point of contact for CAPA related activities within the business unit.

Key Responsibilities include:

* Facilitate product and process Corrective and Preventive Action (CAPA) investigations, by working with Functional Owners and Subject Matter Experts, from issue identification through the implementation of the solution and effectiveness monitoring
* Monitoring quality data sources including, but are not limited to Adverse Events, Audits (Internal, External, Supplier), Complaints, Corrective Actions (Internal, Supplier), Deviations, Field Safety Actions, Nonconformances (Internal, Supplier), and Servicing on a monthly basis via the CAPA Review Board to provide trending analysis on quality issues and performance metrics in line with KPIs in preparation for Management Review
* Perform timely, detailed CAPA engineering tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving
* Project manage all aspects of CAPA activity which includes gaining the commitment of cross-functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines and presenting the data at the CAPA review meeting
* Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformance
* Quality Monitoring spanning the entire Quality Management System (QMS), its elements, and is conducting it through the entire product lifecycle: from design, into operations, supplier controls, acceptance activities, and through post-distribution surveillance
* Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available
* Help facilitate continuous improvement

The successful Quality Engineer will be joining a fast-growing and innovative Quality & Regulatory team, which enables meaningful innovation for customers by collaborating with and guiding the business to achieve quality and regulatory compliance in a rapidly changing environment.

It is essential that the Quality Engineer has demonstrable experience in Quality Engineering and CAPA processes within Medical Devices, with a strong knowledge of ISO13485, preferably with Lead Auditor experience. It is also important that the successful individual has a working knowledge of medical device regulations, including 21CFR and MDD/MDR.

This is a fantastic opportunity for a Quality Engineer who already has experience in the Medical Device sector and would like to join a business that can match their ambition and facilitate progression. If you are a driven Quality Engineer and meet the criteria listed, please APPLY NOW!

Quality Engineer, Farnborough, £40,000-£50,000

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

  • Job Type

    Permanent, Full Time

  • Work Authorisation

    No

  • Industry Sector IT & Internet