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Verification and Validation Specialist

1 month ago

Royston, Barnsley, United Kingdom Oho Group Ltd Full time

Job Title: Verification and Validation Engineer

Job Summary:

We are seeking a skilled Verification and Validation Engineer to join our team at Oho Group Ltd. As a key member of our engineering team, you will be responsible for defining, designing, and executing verification and validation activities to ensure our diagnostic systems meet regulatory requirements and are ready for product launch.

Key Responsibilities:

  • Support verification and validation processes to prepare the system for clinical studies and FDA approval.
  • Implement test plans and protocols, documenting all activities within the Quality Management System (eQMS).
  • Develop Work Instructions and Standard Operating Procedures (SOPs).
  • Collaborate with Engineering, Manufacturing, and Biology teams to achieve regulatory submission and product launch.
  • Ensure compliance with ISO 13485/FDA regulatory requirements.

Qualifications:

  • Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices within an ISO13485/21CFR regulated environment.
  • Experience in writing test protocols aligned with Product Requirement Specifications.
  • A degree in Science or Engineering or equivalent relevant experience.
  • Experience in medical device development and commercialization.

Preferred Skills:

  • Hands-on experience in an ISO13485/FDA regulated environment.
  • Strong background in developing and executing verification and validation protocols.
  • Ability to collaborate effectively with cross-functional teams.

About Oho Group Ltd:

Oho Group Ltd is an innovative and well-funded company dedicated to developing cutting-edge diagnostic systems. We are committed to delivering high-quality products that meet regulatory requirements and improve patient outcomes.