QUALITY ENGINEER II | WEST MIDLANDS | Competitive Salary
A leading life sciences organisation are currently recruiting for a Quality Engineer to join their facility based in the West Midlands area on a permanent basis.
This a full-time onsite position, Monday - Friday.
Reporting to the Quality Engineering Supervisor, the core function of the role is to strengthen the quality system, promote alignment to QA policies and requirements, and drive the execution or quality goals and objectives.
Key responsibilities include:

• Participating in change control activities for documents and manufacturing processes


• Ensure accurate use of quality systems and processes


• Provide mentorship and direction to ensure ISO/Quality system compliance


• Lead non-conformances, complaint records, and CAPAs


• Review batch records for medical device products in accordance with cGMP and GDP


• Support internal and external audits, including audit of batch records and release activities


• Identify and implement improvements using quality data, metrics and Practical Process Improvements (PPI) tools

To be considered for the role candidates must have a degree in Science or Engineering, or a related field, along with relevant Quality / Manufacturing / Engineering or related experience in an ISO 9001, ISO 13485, FDA 21CFR 820 environment.
Demonstrated ability to conduct quality investigations, including RCAs is essential, along with knowledge of Quality standards and a proven track record to collaborate in multi-functional teams.
Experience supporting a team operating automated in-line filling and labelling equipment would be desirable.
An awareness of IVDR and ISO 13485 would also be preferred.

In order to apply for this role please forward your CV to melissa@blackfieldassociates.com or call Melissa on +44 (0) 2392 322 306 for further details.

STR Limited is acting as an Employment Agency in relation to this vacancy.