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Quality Assurance Specialist

2 months ago

Cambridge, Cambridgeshire, United Kingdom TekWissen UK Full time
Job Title: Quality Assurance Specialist

About the Role:

We are seeking a highly skilled Quality Assurance Specialist to join our team at TekWissen UK. As a Quality Assurance Specialist, you will be responsible for providing design control and risk management expertise to medical devices and combination product development programs throughout the product lifecycle.

Key Responsibilities:

  • 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.
  • Supplier & Manufacturing Support:
  • Assess external design companies and suppliers' capabilities related to device development and supply.
  • Support device design and manufacturing investigations during clinical trials and commercial manufacture.
  • Audit & Quality Management:
  • Assist in internal and external audits of the DCoE Quality Management System.

Requirements:

  • Qualifications:
  • BSc, MSc, or PhD 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.
  • Knowledgeable in EN 62366, EN 60601, and EN 62304 standards.
  • Familiar with Human Factors Engineering and device assembly manufacturing processes.
  • Strong attention to technical details and accuracy.
  • Ability to work independently and prioritize multiple tasks.

Competencies:

  • Decisive: Agile learner with the ability to synthesize complex information.
  • Focused: Accountable for meeting the needs of customers and stakeholders.
  • Connected: Effective in building professional relationships with stakeholders.
  • Courageous: Consistent and trustworthy in actions and decisions.
  • Resilient: Adaptable to shifting priorities in response to organizational needs.

Physical Requirements:

  • Ability to sit for extended periods.
  • Willingness and ability to travel.
  • Possession of a valid driving license.