Quality Engineer

LINQM is looking for a talented quality engineer able to work in a dynamic and team environment, including cross-functional teams( R&D, Clinical Affairs, Regulatory), able to problem solve and manage competing priorities. Excellent critical thinking, analytical and communication skills.
What you'll bring
Bachelors Degree in Engineering andminimum2 years of related experience.
Understanding of FDA medical device regulations.
Ability to identify, interpret and apply statistical sampling methods.
Troubleshooting skills and capability to evaluate nonconformance for risk management and process changes.
Knowledge of IEC-60601 standard, and systems engineering a plus.
Six Sigma Belt certification or CQE a plus.
Day to day functions
DesignControl, Design Verification, Design Validation, Specification Development, and Test methods.
Partner with R&D in the design of safe and effective Critical Care (CC) devices; partner with Manufacturing Engineering to develop critical manufacturing processes.
Critical review and approval of design specifications and design changes.
Develop, update, and maintain technical content of risk management files.
Perform Failure Mode and Effects Analysis to identify product risks.
New product development and quality engineering principles.
Perform Failure Mode and Effects Analysis to identify product risks.
Other duties might be assigned.