Validation Quality Assurance Specialist

13 hours ago


Crawley, West Sussex, United Kingdom Inspiration Healthcare Group Full time

Job Title: Product Validation and Verification Expert

Company Overview:

Inspiration Healthcare Group is a leading provider of healthcare solutions, dedicated to delivering high-quality medical devices that meet the needs of patients and healthcare professionals alike.

Job Description:

We are seeking a highly skilled Product Validation and Verification Expert to join our team. As a key member of our product evaluation function, you will be responsible for ensuring that our products meet the highest standards of quality, safety, and performance.

Main Responsibilities:

  • Conduct design and product verification and validation requirements according to Medical Device Regulations.
  • Produce V&V plans, protocols, reports, and perform the product testing where necessary.
  • Design, develop, and validate appropriate test methods, including automated tests.
  • Perform data analysis/reviews of test results.
  • Participate in risk management and FMEA exercises.
  • Participate in requirement reviews.
  • Interface with design, marketing, clinical, manufacturing, and quality teams to ensure the product evaluation function is fully integrated within the project team.
  • Conduct programs for extended life/reliability testing of new products.
  • Ensure usability is considered within the design of new products and that the usability process is applied.
  • Interface with external test houses.
  • Maintain and create biocompatibility reports and clinical evaluation reports.
  • Undertake literature searches and perform analysis of novel technological/clinical research.
  • Undertake all work in accordance with the quality management system.

Requirements:

  • Bachelor's degree in a relevant field such as engineering, science, or technology.
  • Minimum 2 years of experience in product validation and verification, preferably in the medical device industry.
  • Strong understanding of Medical Device Regulations and quality management systems.
  • Excellent communication and teamwork skills.

Benefits:

  • Competitive salary: $90,000 - $110,000 per annum, depending on experience.
  • Ongoing professional development and training opportunities.
  • A dynamic and supportive work environment.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.


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