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Senior Quality Engineer

Location: Cambridge, Cambridgeshire Salary:
Sector: Pharma & Biotech Type: Permanent

Senior Quality Engineer - Cambridge - £55,000

I am currently supporting a growing Pharmaceutical and Medical Device manufacturer based in Cambridge in their search to bring on an experienced Senior Quality Engineer.

You will be tasked with managing one of their key products while also managing their suppliers. This role would be ideal for an individual who is looking to take the next step up into an environment that will offer integral support into their development.

Responsibilities:

  • Implement protocols and methods (including SOP's) to ensure that incoming material and manufactured products are compliant with internal requirements as well as to standards/regulations.
  • Drive Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, scrap reduction and Supplier Quality improvement and drive continuous quality improvement projects with cross-functional teams.
  • Drive and manage corrective and preventive actions for issues related to quality.
  • Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements.
  • Perform audits (Product-Specific and Quality System) and follow up on closure of any non-conformances; support supplier approval process and maintenance of the Approved Suppliers List and implement Quality Technical Agreements.

Requirements:

  • Experience of working in a product development environment utilising CMOs for manufacture and supply
  • Proven ability to use the quality, complaints, design control, corrective and preventive action, risk management, and non-conforming product systems and to extract and drive improvement initiatives.
  • Demonstrable experience in supplier quality management: quality concepts/tools/methods (e. g. FMEA, IQ/OQ/PQ, MSA, etc.), quality issue resolution and quality monitoring measures.
  • Highly experienced in leading internal and external audits

Shortlisting for this position has begun with a view to progressing to initial interviews over the next couple of weeks.

For further information on this position please contact Sarah Irvine at Real Staffing. We also offer shopping vouchers for any successful referrals so if you know of anyone who could be suitable do feel free to get in touch.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales