Senior Quality Engineer

About Genalyte 
Since 2007, Genalyte has been guided by the vision of taking a single drop of blood, performing panels of tests and receiving results within a few minutes. As we look to the future, Genalyte’s technology will transform health care- moving lab testing from the lab into the physician’s office.  

We are well funded with outstanding growth potential. We are looking for individuals inspired by our technology and vision, who are eager to be at the ground level of this collaborative and entrepreneurial company. 

We want to hire individuals who are interested in creating an innovative, fast-paced and dynamic work setting. We offer a competitive salary and benefits package to attract, motivate, and retain the highest caliber of employee.

About the Role 
We are seeking a Quality Engineer that will establish and maintain appropriate Quality Management System (QMS) consistent with ISO 13485:2016 and cGMP (QSR 21 CFR part 820) in a start-up environment. The resultant QMS must address the needs of design control, GMP manufacture, software and reagent test kits for in vitro diagnostic device.  Ultimately the QMS needs to support ISO 13485:2016 certification and surveillance audits.

Responsibilities
  • Implement and maintain QA programs and systems
  • Manage quality events
  • Analyzing trends and work towards continuance improvement
  • Represent the QMS in communications

About You 
This role requires a approximately 5-8 years of quality experience in an FDA regulated environment, in the medical device, or diagnostics field. Beyond this requirement, a completed Bachelor's Degree in chemistry, biochemistry, microbiology, engineering, or a related discipline is not a must, but a plus. Our most successful candidates come to us with great communication skills, the strive to work towards continuance improvement and ability to interact cross-functionally independently. 

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