Quality Assurance Manager

Counsyl is a health technology company that offers DNA screening for diseases that can impact men, women and their children. The Counsyl philosophy is simple: screen for diseases where advanced knowledge makes a difference in health outcomes, whether it’s changing a behavior, pursuing preventative measures, or simply preparing for what lies ahead.

We currently seek to hire a QA Manager to help us create Quality Management SOPs and manage the Quality program for our highly-automated laboratory. You will collaborate with teams across the organization to ensure our lab continues to process our patient samples with the up most quality and integrity.

* Optimize robust Quality Management System tailored to Counsyl’s fast-paced engineering environment * Refine processes and QA strategies to ensure compliance with CLIA and FDA regulations * Define QAIs, present quality metrics, and utilize data to drive quality improvement projects * Work with different departments to define quality indicators and implement monitoring strategies * Participate in Quality Systems audits * Oversee occurrence management system, non-conformance event tracking, root-cause analyses, and follow-up corrective and preventive actions. * Implement document control structure and organization as well as electronic records management in the most efficient manner possible

* Experience working full-time in Quality for 5+ years in the Medical Device or Diagnostics field * Bachelor’s of Science degree * Experience managing CAP and CLIA quality systems, as they relate to diagnostics (Required) * Experience managing QSR compliance * Experience with high-volume LDTs and in-house reagent manufacturing * Experience implementing Quality Management System * Experience with robust document controls systems * Experience with design control and design history * Ability to effectively articulate messaging and purpose to partner with other parts of our organization * Experience with a highly automated lab preferred