Senior Verification and Validation/quality Engineer - Paddington, United Kingdom - Sigma Recruitment Ltd
Description
Opportunity for a senior verification and validation/quality engineer with medical device industry experience to join a well-financed, innovative UK company focusing on delivering and implementing artificial intelligence solutions.
The remuneration package on offer is very competitive, with a basic salary of between £50,000 and £70,000 depending on experience.
Why you should apply
This opening is an ideal opportunity for a senior quality engineer/verification and validation engineer passionate about the medical device industry.
The employer has a diverse and talented senior team who will afford you plenty of autonomy and coach youto fulfil your potential.
About the company
The business is ambitious and aims to be a globally recognised scientific innovator, developing working FDA/CE tools for large multinational partners and providing new solutions for diagnostics and treatment to improve human health.
Rather than replicating the existing medical device product development models, the company is innovating the field with agile development techniques and cutting-edge science to bring rapid evolution of medical device products to the market.
About the senior verification and validation/quality engineer
As the senior verification and validation/quality engineer, you will join a team of world-class scientists and globally recognised industry specialists.
Further duties will include:
- Establishing, maintaining and improving quality systems processes and procedures for verification and validation
- Identifying resources, training, equipment and components necessary to support successful verification and validation.
- Ensuring compliance with standards and researching to understand new regulatory requirements related to productspecific requirements, design controls and verification and validation.
- Producing validation and verification plans, protocols, reports, risk management reviews and performing product testing
- Participating in risk management, usability and design review exercises
- Reviewing and contributing to project phase reviews and design input documents
- Acting as the critical point of contact with external test facilities (for example, safety testing, EMC, biocompatibility etc.)
- Extensive experience running verification and validation projects within a medical device company working to IEC 6060
- Experience in usability testing.
- Involvement with medical device design/development from concept to postmarket followup.
- Ideally, experience with medical products that have software or disposable elements.
- Willingness to travel to the United States on an occasional basis.
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