Senior Quality Assurance Specialist

2 days ago

Cambridge, Cambridgeshire, United Kingdom Hyper Recruitment Solutions Full time

Job Title: Senior Quality Assurance Specialist

Job Summary:

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Hyper Recruitment Solutions. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the highest standards of quality and regulatory compliance throughout the product lifecycle.

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 facilitate 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.

Requirements:

  • Relevant degree in a science or engineering discipline such as chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, or chemical engineering.
  • Proven industry experience in pharmaceutical combination product / drug delivery and/or device industries.
  • A working knowledge and practical experience with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.

What We Offer:

As a Senior Quality Assurance Specialist at Hyper Recruitment Solutions, you will have the opportunity to work with a leading pharmaceutical company based in the Cambridge area. You will be part of a dynamic team that is passionate about delivering high-quality products and services.

Key Skills:

  • Quality Assurance
  • Regulatory Compliance
  • Design Control
  • Risk Management
  • Product Development

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