Senior Quality Assurance Specialist

5 days ago

Cambridge, Cambridgeshire, United Kingdom Russell Tobin Full time
Job Description

Job Title: Senior Quality Assurance Specialist

Company: Russell Tobin

Location: Cambridge (Hybrid with 2-3 days onsite per week)

Job Type: Full-time

Salary: upto £21.62 PAYE and £24 per hour Umbrella

Job Summary

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Russell Tobin. As a Senior Quality Assurance Specialist, you will be responsible for leading design control and risk management activities for combination product development programs.

Key Responsibilities
  • Lead Design Control and Risk Management: Ensure deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
  • Support and Facilitation: Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
  • Quality and Regulatory Compliance: Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
  • Design Validation: Provide input and support to design validation including, but not limited to, human factors engineering assessments.
  • Supplier Assessment: Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
  • Device Investigations: Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
  • Regulatory Submissions: Support the generation of all regulatory submission data and content for assigned device projects.
  • Audits and Compliance: Support internal and external audits of the DCoE Quality Management System.
Requirements
  • Education: BSc in appropriate science & engineering discipline with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries OR MSc in appropriate science & engineering discipline with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries OR PhD in appropriate science & engineering discipline.
  • Experience: 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.
  • Technical Skills: Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
  • Soft Skills: Excellent communication (e.g., oral, written, presentation) and interpersonal relationship skills.

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