Quality Engineer

  • Portland, Me
  • This position has been filled

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.