Our client is a global leader in point of care diagnostics – for treatment and management of diseases. The successful Quality Engineer will support design and development of medical device products and facilitate the application of design controls and risk management.
• Review and approve of validation methods and protocols, test methods, statistical analysis methods and specification development.
• Review new and modified product designs for quality.
• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and Medical Device Directives.
• Act as a key contributor to the development and validation plans and processes.
• Act as a key team member in establishing, communicating and mitigating risks. • Ensure successful transfer of new products to manufacturing.
• Review production validation methods.
• Bachelors’ degree (B.S.) or equivalent combination of education and experience.
• a few years related experience and/or training in a Quality and/or Development Position.
• Working knowledge of Design Control Regulations and experience with hardware, software and biotech systems.