Quality Assurance Specialist

£38,000-£45,000

Cambridge

Austin Vita is recruiting for a Quality Assurance Specialist to join a market-leading business. The Quality Engineer has a genuine opportunity to play their part in the client’s continued success and it is a great time to be joining the business. The company prides themselves on their culture and they try to tailor to everyone’s needs.

As well as being a great company to work for from a cultural perspective, the work is genuinely interesting and challenging as well. The Quality department is currently relatively small, so the individual joining the business will play a pivotal part in the day to day operation of the business.

Responsibilities:

* Ensuring compliance with national and international standards and legislation currently ISO13485 and ISO9001.
* Understanding and experience of CAPA and non-conformance.
* Experience of Medical Devices Vigilance Reporting.
* Solid working knowledge of customer complaint investigations and trending activities
* Fully understand and have experience of ISO14971 Medical Devices Risk Management.
* Work closely with Technical and Business Managers to manage manufacturing procedures and systems to achieve and maintain current certification
* Defining quality procedures in conjunction with operating staff.
* Setting up and maintaining controls and documentation procedures.
* Liaising with customers’ auditors and ensuring the execution of corrective action and compliance with customers’ specifications.
* Writing technical and management system reports.
* Effectively interact with Production and Technical Support teams to maintain product supply and help introduce new products.
* Working with purchasing staff to establish quality requirements from external suppliers.
* Able to write procedures, technical reports.
* Able to review and critique technical reports in order that compliance is maintained.
* Mentoring and coaching both within the Quality Assurance Team and throughout the business to improve the company skillset and understanding of the QMS.

It is essential that the successful Quality Assurance Specialist has previous experience within Medical Devices and a strong knowledge of ISO13485.

If you are an experienced Quality Engineer and meet the criteria listed, please APPLY NOW!

Quality Assurance Specialist, Cambridge, £38,000-£45,000

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.