Manager - Instrumentation, Design & Development Quality

Proclinical are partnering with a medical technology and device organisation who are recruiting for an individual to join their team. This role is on a permanent basis. The opening position that is currently available is for a Manager - Instrumentation, Design & Development Quality.

Responsibilities:

• Assist the instrumentation divisions to guarantee audit ready every day and compliance with the company's QMS.
• Handle all QA actions affiliated with instrumentation design & development, change management V&V, technical investigations, and division QA assistance.
• Accountable for hiring, managing, training & developing the QA instrumentation team to deliver business objectives.
• Handle all design quality actions in connection to instrumentation.
• Offer quality knowledge and direction into quality event & CAPA reports to guarantee compliance with the company's processes, efficient QA feedback to divisions in a timely manner as well as raising any high-risk concerns.
• Collaborate with quality staff across sites to be in line with quality needs for the company's business and guide/assist on quality improvement projects.
• Supply quality knowledge into change management and design transfer affiliated with instrumentation in compliance with company processes.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to a degree level in a pertinent field.
• Demonstrable experience with instrument design and development and manufacturing quality procedures.
• Familiarity with medical device and/or in vitro diagnostics quality procedures, which involves design evaluation, change management, design transfer, risk management, non-conformance management, CAPA, problem solving tools, etc.
• Prior involvement in people management, as well as working and arranging actions across multidisciplinary teams.
• Computer literacy.

If you are having difficulty in applying or if you have any questions, please contact Joe Dykes at j.dykes@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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#QACompliance