Product Design Assurance Specialist

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom Healthcare Businesswomen's Association Full time

Job Description Summary

Sandoz is a global leader in sustainable Biosimilar and Generic medicines, undergoing an exciting and transformative period.

The Design Assurance Engineer ensures project compliance to relevant regulations and to external and internal standards for design control activities and project documents.

  1. Prepare medical device and drug/device combination product design and development documentation and compilation of Design History Files and/or Technical Files in collaboration with multi-disciplinary project teams.
  2. Interface with Quality Assurance functions to ensure compliance with company QMS and international standards and regulations.
  3. Guide and/or support project teams through design assurance and compliance activities and ensure best practices.
  4. Participate in and/or lead design reviews.
  5. Prepare medical device and drug/device combination product risk management documentation.

What you'll bring to the role:

Essential Requirements:

  1. Masters, PhD, or university degree in the field of engineering, quality management, life sciences, or other relevant subject.
  2. Good working knowledge of medical device and drug-device combination product development processes including design verification.
  3. Proven track record (3+ years) as part of a medical device development team within a pharmaceutical, medical devices, and/or combination products setting.
  4. Experience working within the ISO13485 medical devices quality framework and in-depth knowledge of GMP, EU, and FDA regulatory requirements.
  5. Experience working with ISO14971 risk management for medical devices.
  6. Excellent command of English (verbal and written).

Benefits:

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.



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