New

Supplier Quality Specialist III (Contractor)

Brisbane, California

About this opportunity:

The Supplier Quality Specialist III/IV plays an integral role in supporting quality activities related to Supplier Management in accordance with FDA, ISO, and other IVD regulations. This individual also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation 21 CFR § 820 and ISO 13485 as well as CLIA, CAP, and applicable state requirements. In this role you will facilitate the supplier compliance program (external audits, drive improvement in supplier performance, supplier development, supplier selection and qualification). In addition, this role will support the quality assurance activities in partner development as needed. 

What you’ll do:

  • Maintain the approved supplier list and supplier audit schedule
  • Drive compliance with applicable quality management system requirements, engaging in supplier corrective actions as needed
  • Conduct external and internal quality audits to identify potential areas of risks and drive continuous improvement
  • Lead establishing quality agreements with critical suppliers, and quality of supplier records
  • Actively participate in supplier quality related communication and feedback.
  • Lead the processing of supplier change notifications 
  • Engage directly with Freenome suppliers to drive quality and process improvements in order to continuously improve the quality of product and services received
  • Maintain supplier non-conformances to closure and effectiveness review, working with impacted departments
  • Maintain organized records that demonstrate compliance to all company processes, regulations, and the company’s QMS
  • Support routine Quality processes such as document control, employee training, investigating non-conformances, quality metrics, etc.

Must haves:

  • Minimum of a Bachelor's degree in a life science field (genetics or molecular biology preferred) or equivalent experience
  • 5+ years of experience in manufacturing operations, clinical laboratory operations, quality, or supplier quality
  • ISO 13485 certified Lead Auditor or Certified Quality Auditor (CQA)
  • Effective problem solving skills and ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
  • Proficiency in Word, Excel, PowerPoint or Google Workspace and experience with document management systems and document sharing systems
  • Ability to prioritize and multitask while maintaining a positive and collaborative attitude
  • Experience with both internal audits or external audits
  • Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
  • Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders
  • Flexibility to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
  • Drive for results and continual improvement
  • Travel 10 - 30% domestically and potentially internationally, potentially more as needed

Nice to haves:

  • Certified Quality Engineer, CQE (ASQ)
  • Experience in quality system methodologies including but not limited to CAPA, Lean, 5 Why's, Pareto Analysis, Six Sigma
  • Experience with statistical process control (SPC) techniques to evaluate and improve process performance
  • Experience with process validations

Additional information:

Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

#LI-HYBRID

Create a Job Alert

Interested in building your career at Freenome? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Freenome’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.