Quality Engineer
FIXED TERM CONTRACT - 23 months
Medical Device/ Pharma
ASAP start
Herts
£40k Pro rata

Our hugely successful global medical device company is looking to recruit a Quality Engineer with experience of EMDR.
You will be degree educated in a relevant subject and come from a medical device or pharma background.

You will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:

Work closely with operations and the business functions to ensure quality performance of product and processes.

Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.

Lead and participate in the development and improvement of the manufacturing processes for existing and new products.

Analysis and review of concession requests.

Review and approval of change management activities.

Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.

Support execution and analysis of QATs.

Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.

Proficiency in and makes continuous strides towards optimisation of inspection methods and sampling. Support First Article Inspections.

Proficiency in statistical methods and application.

Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.

Assist in the development, responsible for review & approval of process and equipment validation/qualification.

Support manufacturing transfers to other plants/facilities, leading quality activities.

Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.

Coach and mentor others in quality topics and activities.

Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.

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