Sr. Quality Specialist
Sr. Quality Specialist
Posted on :
28-08-2025
Employer Active
1 Vacancy
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Monthly Salary
$ 85000 - 102000
Vacancy
1 Vacancy
Posted on :
28-08-2025
Job Description
Everlywell is a digital health company pioneering the next generation of biomarker intelligencecombining AI-powered technology with human insight to deliver personalized actionable health answers. We transform complex biomarker data into life-changing insightsseamlessly 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 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 were just getting started. Fueled by AI and built for scale were 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 Everlys 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 Everlys 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:
- Bachelors 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.
This salary range for this position is $85000 - $102000 based on the selected candidates 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.
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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