Validation Quality Assurance Specialist
13 hours ago
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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