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Quality Assurance Engineer

2 months ago

Cambridge, Cambridgeshire, United Kingdom TekWissen UK Full time

Job Title: Quality Assurance Engineer – Compliance

Location: Remote (2-3 days on-site per week)

Work Hours: 37 hours per week

Job Overview:

The Quality Assurance Engineer – Compliance will be responsible for providing design control and risk management expertise to medical devices and combination product development programs throughout the product lifecycle. This includes the generation and review of design history and risk management file components, as well as collaboration with cross-functional development teams.

  • Design Control & Risk Management:
  • Lead and manage design control and risk management activities for combination product development programs.
  • Ensure deliverables are compliant with clinical trials and commercial licensure requirements.
  • Facilitate risk management activities with external design companies and manufacturing facilities.
  • Compliance & Validation:
  • Ensure product development activities comply with internal and external quality and regulatory standards.
  • Provide input and support for design validation, including human factors engineering assessments.
  • Support regulatory submission data generation for assigned device projects.
  • Support device design and manufacturing investigations during clinical trials and commercial manufacture.
  • Audit & Quality Management:
  • Assist in internal and external audits of the Quality Management System.

Educational & Experience Requirements:

  • Qualifications:
  • Bachelor's, Master's, or Ph.D. in a relevant science or engineering discipline (e.g., chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering).
  • Experience:
  • Minimum 2 years of relevant experience in the pharmaceutical combination product and/or device industries.
  • Experience in design controls and risk management for combination products.
  • Familiarity with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation.

Technical Skills:

  • Proficient in ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation.
  • Familiar with Human Factors Engineering and device assembly manufacturing processes.

Competencies:

  • Decisive: Agile learner with the ability to synthesize complex information.
  • Connected: Effective in building professional relationships with stakeholders.
  • Resilient: Adaptable to shifting priorities in response to organizational needs.
  • Willingness and ability to travel.
  • Possession of a valid driving license.