Burlingame, California /
Clinical – Lab Operations /
Named by Rock Health as the Best Digital Health Company to Work For, Color is a leading healthcare technology company. Color is building and delivering technology-enabled healthcare to millions of people. Through partnerships with public and private partners including governments, employers and health systems, Color’s infrastructure and software enables large populations to receive essential healthcare services directly where they live or work. This includes testing and telehealth services for preventive health and infectious disease management.
Since March 2020, Color has mobilized to address the pandemic by leveraging its platform to scale COVID-19 testing programs around the country. Color’s platform is used by more than 100 major employers, universities and public health institutions, such as the City of San Francisco, the State of California and PerkinElmer, community-based efforts in Oakland, and others, to deliver critical health programs. For more information about Color and its response to COVID-19, visit www.color.com.
By investing in the technology that ensures easy and affordable access to healthcare, Color is creating the infrastructure that will serve us for decades to come. Apply to join Color and do some of the most important work of your career. If you are not sure that you're 100% qualified, but are up for the challenge - we want you to apply!
We are looking for someone to join our Quality Assurance team to help support the Quality Management Systems (QMS) at Color, ensuring compliance with regulatory standards such as 21 CFR Part 493 (CLIA), CAP, and New York State Department of Health (NYSDOH). The Quality Engineer will work to address nonconformances, deviations, corrective and preventive actions (CAPA) and supplier quality issues that impact the clinical laboratory operations. This position may also support internal and external audits, document control, training, complaint handling, and tracking and trending of quality metrics. This is a full-time employment position.
How You'll Contribute
- Overseeing the process for nonconformances, deviations, CAPAs, and supplier corrective action requests (SCAR). Ensure proper identification, initiation, documentation of investigation details, execution of immediate correction, implementation of corrective/preventive actions, timely closure, and monitoring and trending of metrics.
- Creating, updating, reviewing and developing QMS standard operating procedures and other supporting work instructions per CLIA, CAP, and NYSDOH regulations.
- Perform QA review of new or relocated equipment qualification (IQ/OQ/PQ) documentation.
- Create, implement, and maintain a Supplier Quality program which includes supplier questionnaires, maintain Approved Supplier List (ASL), supplier audit schedule, performing supplier audits, issuing SCARs, and monitoring supplier performance.
- Create, implement, and maintain an Internal Audit program as the lead auditor, which includes an internal audit schedule, performing internal audits, generating internal audit reports, and ensuring timely closure of internal audit findings.
- Support internal and external audits (CLIA, CAP, NYSDOH, supplier, customer/partner)
- Provide training and awareness in the organization for nonconformances, deviations, CAPAs, Supplier Quality, document control, external/internal audits, and complaint handling programs.
- Assist in building out processes to support new regulatory requirements such as Post Market Surveillance, Risk Assessment, Design Control.
- Collaborate with cross-functional teams and provide QA guidance and best practices on projects and activities that require QA feedback.
- Engage in continuous improvement activities by identifying opportunities and recommending improvements in the QMS processes.
- Maintain knowledge of relevant quality and regulatory standards to meet changing requirements.
- Participate in special projects and perform other duties as assigned.
Our Ideal Candidate Will Have:
- A Bachelor’s degree or equivalent in science, engineering, or related field.
- At least 5 years of experience in CLIA/CAP laboratories, medical devices, or life sciences industries. 4 years experience working in a Quality role preferred.
- Audit experience - internal audits, third party audits and/or regulatory audits.
- Knowledge of CLIA, CAP, NYSDOH regulations.
- Prior EU IVD regulatory experience
- Prior Medical Device / IVDR experience
- Excellent interpersonal, verbal, and written communication skills.
- Independent worker, self-starter with strong organizational and planning skills.
- Prior experience in a start-up environment that is fast paced and willing to accept temporary responsibilities outside of the initial job description.
Nice to Have
- Professional certification (i.e. American Society of Quality certification in Quality Engineering, Quality Auditing, etc.).
- Next generation sequencing (NGS) experience.
- Familiarity with SQL and Tableau.
Color is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Color prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Color conforms to the spirit as well as to the letter of all applicable laws and regulations.
COVID-19 Vaccination Requirement: Color requires anyone working onsite or visiting Color’s offices to confirm they are fully vaccinated against COVID-19 unless a medical or religious accommodation is timely requested and approved. Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Color.