Quality Engineer

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom SRG Full time £42,000 - £65,000 per year

Job Title -
Quality Engineer

Location –
Cambridge

Contract -
12 months

Working pattern -
Hybrid - Cambridge (2.5 days per week / 5 days per fortnight onsite)

Salary -
PAYE - £16.77 p/h up to £25.98 p/h, Umbrella - £18.79 p/h up to £29.12 p/h

SRG are working with a global pharmaceutical company that are seeking a
Quality Engineer
to join their busy team.

Key responsibilities:

  • Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
  • Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
  • Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
  • Provide input and support to design validation including, but not limited to, human factors engineering assessments.
  • Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
  • Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
  • Support the generation of all regulatory submission data and content for assigned device projects.
  • Support internal and external audits of the DCoE Quality Management System.
  • Identify, communicate, and develop strategies to improve combination product systems.

Basic Qualifications:

  • BSc, MSc or PhD in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries
  • History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
  • Experience in design controls for combination products.
  • Device risk management expertise.
  • Familiar with Human Factors Engineering - Usability Engineering.
  • Understand project management methodologies and capable to provide technical leadership for projects.
  • Familiar with device assembling manufacturing processes.
  • Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
  • Working knowledge of EN 62366, EN 60601, and EN 62304.
  • Able to learn and apply established procedures in a reliable and consistent manner.
  • Capable of working independently with minimal supervision.

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