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Principal Quality Assurance Engineer

  • Location: Santa Clara, Santa Clara County, California
  • Salary: 50-60 per hour
  • Job Type:Contract

Posted 23 days ago

  • Sector: Engineering
  • Start Date: 2021-09-07
  • Job Ref: 21-18340
Location REMOTE can sit anywhere in the country but need to easily travel to west coast and mid west, 30% of the time.

Schedule standard hours Monday-Friday (OT as needed)

Duration through July 2022, possible extensions

Job Posting Title
Quality Assurance Lead

Job Description
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At the client, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
Our dedicated team of about 14,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
If you are seeking a meaningful, impactful, and stimulating career, look no further.
Customer is seeking a Quality Assurance Lead to join the Quality Regulatory & Medical team. The Quality Assurance Lead will be responsible for providing guidance and direction on quality requirements, agreements and activities conducted by Customer Hub employees and contracted laboratories. They will provide day-to-day support in CLIA and laboratory requirements as well as develop and maintain quality procedures and activities required to uphold effective operations.

Job Responsibilities
Develop Quality Agreements between Customer and contracted laboratories
Revise the HUB Quality Management Plan (QMP0 as required per contractual agreement
Provide Quality support during inspection of Customer Hub or contracted partners
Manage the contracted laboratory audit schedule and process; maintain all records of qualification and for cause audits
Conduct remote or in person audits of laboratories
Maintain qualification files
Collect audit response and corrective action plans from contracted laboratories
Evaluate audit response for suitability with Customer , CLIA and laboratory requirements
Provide compliance and key metric reports to business partners and senior management.
Primary liaison between the Customer Hub and contracted laboratory Quality Management teams
Monitor reports of quality defects, nonconformances, deviations or adverse events as they pertain to the Customer Hub and agreements with contracted laboratories
Develop and foster strong relationships with key stakeholders within Customer and contracted laboratory facilities
Oversee execution of operational activities within the Customer Hub
Collect, analyze, measure and monitor compliance and performance against objectives of applicable QMP(s).
Lead procedure development activities required for the effective operation of the Customer Hub.
Work on assigned projects and initiatives with limited supervision
Actively participate in business review meetings as required
Other duties as assigned

Job Qualifications
Bachelor's Degree in Health Sciences or relevant field; or equivalent work experience.
Combined 10+ years of experience in Quality Assurance and Clinical Laboratory Management with a minimum of 5 years in Quality Assurance.
Certified Lead Auditor, CLIA

o BS, MS, or PhD with a degree in chemical, physical or biological science or medical laboratory technology. OR
o Associate Degree in laboratory science, or medical laboratory technology prior to April 25, 1995 OR
o High School diploma prior to April 25, 1995 AND either:
Graduate of MLT or CLT program or
Hold a US military Medical Lab Specialist Certification
o Copy of the diploma, that states the type of chemical, physical, biological or clinical laboratory/medical technology science degree and the major discipline MUST BE PROVIDED
Applicable degrees include BS in Biology, Medical Biology, Molecular Biology, Cellular Biology, Cancer Biology, Virology, Microbiology, Genetics, Biochemistry, Immunology, Physiology, Chemistry, Physics, Medical Technology or Clinical Laboratory Science from an accredited institution).
Other disciplines may be considered, but they have to have 12-16 semester hours of Biology and Chemistry OR 18-24 quarter hours of Biology and Chemistry
If the diploma does not state the disciple, i.e., just states Bachelor of Science or Arts, then a copy of the transcript(s), official or unofficial, specifying the degree and the major area of discipline awarded must be provided.
o If a worker has foreign education, then the worker must be able to provide a copy of an international education equivalency evaluation from a reputable agency that is recognized by either NACES or AICE to determine if the evaluation agency is itself credentialed. or

Preferred Qualifications
Strong technical writing skills
Ability to work in a matrixed organizational structure, developing strong relationships with multi-national business partners.
Exceptional attention to detail with a process driven mindset
Ability to take direction and multi-task in a fast-paced environment
Ability to work independently with minimal supervision
Superior interpersonal, verbal, and written communication skills
Exceptional organizational, negotiation, and problem-solving skills