QA Manager

Organization
Counsyl
Job Location
180 Kimball Way
South San Francisco, CA 94080
Benefits

Discretionary time off with no maximum. Company subsidized Medical, Dental, and Vision Insurance. Company paid Life Insurance. Catered lunch, on-site gym, company sponsored events and outings. 401k- Traditional or Roth (no matching). Equity in the form of RSUs.

Job Description

Over the last few years, Counsyl has grown from a dorm room startup to become one of the largest clinical genome centers in the world, processing over 500,000 samples to date. 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 upmost quality and integrity.

What you'll do

 

  • 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
Requirements
  • 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, or 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
How to Apply

Go to https://www.counsyl.com/careers/qa-manager/ and click Apply. Be sure to attach your resume and cover letter.

About Our Organization

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. The Counsyl team includes an accomplished group of problem-solvers — top engineers, scientists, and designers — who are taking the lead on building the modern clinical laboratory. Scientific rigor, custom robotics, and software are at the heart of every Counsyl product, resulting in better, faster and more affordable screens that are broadly accessible. Beyond the laboratory, Counsyl offers doctors and patients a technology platform for results delivery in real time, with on-demand access to board-certified genetic counselors. Counsyl has screened more than 500,000 patients and served more than 6,000 health care professionals in its CLIA-certified, CAP-accredited and NYS CLEP-permitted clinical laboratory. The company has raised a total of $102 million and is privately backed by RSTP, Goldman Sachs Asset Management, Founders Fund, Felicis Ventures, David Drummond, and other high profile investors.   

Noteable articles/videos:

 

http://techcrunch.com/2013/04/23/counsyl/

https://vimeo.com/63141778

http://mashable.com/2015/04/15/future-of-preventive-care/

Students whose classmates are interested in science are more likely to think about a career in science, technology, engineering, and mathematics, a new study says.

CNBC reports that the genetic counseling field is expected to grow as personalized medicine becomes more common.

Gladys Kong writes at Fortune that her STEM background has helped her as a CEO.

Social scientists report that the image of the 'lone scientist' might be deterring US students from STEM careers.