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Everlywell

Sr. Quality Specialist

On site Legal
Added
15 days ago
Location
Type
Full time
Salary
$85K - $102K

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Related skills

qms compliance iso 13485 ivdr mdsap

Everlywell is a digital health company pioneering the next generation of biomarker intelligence—combining AI-powered technology with human insight to deliver personalized, actionable health answers. We transform complex biomarker data into life-changing insights—seamlessly integrating advanced diagnostics, virtual care, and patient engagement to reshape how and where health happens.

Over the past decade, Everlywell has delivered close to 1 billion personalized health insights, transforming care for 60 million people and powering hundreds of enterprise partners. In 2024 alone, an estimated 1 in 86 U.S. households received an Everlywell test, solidifying our spot as the #1 at-home testing brand in the country. And we’re just getting started. Fueled by AI and built for scale, we’re breaking down barriers, closing care gaps, and unlocking a more connected healthcare experience that is smarter, faster, and more personalized.

The

Sr. Quality Specialist plays a critical role in the execution and continuous improvement of Everlywells Quality Management System (QMS), ensuring compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, IVDR, and other applicable regulatory standards. This individual acts as a

peer leader and subject matter expert within the Quality team, driving excellence in compliance, process performance, and audit readiness across Everly’s regulated manufacturing and diagnostics operations. While not a supervisory role, the Sr. Quality Specialist will

mentor and coach peers, champion cross-functional problem solving, and lead quality initiatives.

Quality Systems & Compliance Responsibilities:

  • Drive execution of assigned QMS processes (e.g., document control, CAPA, internal audits, nonconformance investigations, supplier quality).
  • Monitor, interpret, and ensure alignment to evolving FDA regulations (21 CFR Part 820), ISO 13485, IVDR, and applicable guidance.
  • Lead and support internal and external audits (e.g., FDA, notified body, customer), including audit readiness, hosting, and CAPA management.
  • Conduct and lead supplier quality audits, ensuring compliance with Everly’s supplier quality requirements.
  • Perform gap assessments of QMS elements and lead improvement projects to close compliance gaps.

    • Manufacturing Quality Responsibilities:

  • Support incoming inspection and final product release of regulated test kits and diagnostic components.
  • Partner with Manufacturing, Supply Chain, and Laboratory teams to address quality issues, implement root cause analysis (e.g., 5 Whys, Fishbone, FMEA), and prevent recurrence.
  • Lead quality review of deviations, non-conformances, change control, and validation activities in alignment with GMP.

    • Leadership & Mentorship Responsibilities:

  • Serve as a peer leader to other Quality Specialists and Technicians, offering guidance, coaching, and support.
  • Champion Everlywells values and competency model by fostering collaboration, trust, and a culture of continuous improvement.
  • Facilitate knowledge sharing through training sessions, documentation of best practices, and process standardization.

    • Training & Communication Responsibilities:

  • Develop and deliver training on quality topics including QMS, cGMP, audit readiness, and regulatory requirements.
  • Communicate effectively with cross-functional stakeholders, including Manufacturing, Supply Chain, Clinical, and Product teams.

    • Education & Experience Qualifications:

  • Bachelor’s degree in a scientific discipline required.
  • 5+ years of experience in a quality role within a regulated manufacturing or diagnostics environment.
  • Experience supporting FDA inspections and ISO audits required.
  • Quality certifications (e.g., CQA, CQE, or equivalent) highly desirable. Six Sigma certification is a plus.

    • Technical Competencies:

  • Strong understanding of FDA 21 CFR Part 820 (QSR) and ISO 13485, ISO 14971, IVDR, and MDSAP
  • Skilled in root cause analysis and CAPA methodology.
  • Proficient with QMS tools, EDMS, ERP systems (e.g., NetSuite), and data trending.
  • Familiarity with risk management and validation principles.

    • Physical Requirements:

  • Ability to lift and move products up to 45 lbs.
  • Extended periods of standing, walking, or sitting as required by tasks.

    • Additional Information

    This salary range for this position is $85,000 - $102,000 based on the selected candidate's qualifications, market data/ranges, location, and internal equity. This position is also eligible for an annual bonus, health, dental, vision & mental health insurance, 401(k) with company match, Flexible PTO, a monthly $100 wellness stipend and various other perks.

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