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Everlywell · 2 months ago

Lab Quality Manager for Moderate Complexity CLIA Lab

Hoffman Estates, IL

Full-time

Onsite

Senior Level, Lead/Staff

$100K/yr - $120K/yr

8+ years exp

Everlywell is a digital health company pioneering biomarker intelligence through AI-powered technology and human insight. The Lab Quality Manager will lead the quality management program for the clinical chemistry laboratory, ensuring compliance with regulatory standards and maintaining audit readiness.

Health CareHealth DiagnosticsMedical

H1B Sponsor Likely

Responsibilities

Maintain laboratory licensure and accreditation (CLIA, CAP, NYS) through periodic renewals, new applications, method submissions and managing the proficiency testing program

Serve as the liaison between the clinical laboratory and accrediting agencies

Administer and manage the document control system, incident reporting system and personnel documentation

Review all laboratory procedures and validation documentation for compliance following regulation and guidance

Assure proper qualification of laboratory personnel according to regulatory standards

Perform regular internal quality audits in all laboratory sections; follow up with recommendations, corrective, and preventive actions as needed

Identify procedural and systemic compliance risks and recommend continuous improvements that complement existing practices

Review and follow up on non-conformances, deviations until resolution. Initiate corrective and preventative actions to address system deficiencies and drive implementation of corrective action plans

Oversee and manage quality system related meetings, collect and trend key performance indicators

Interface and collaborate with laboratory personnel to educate, provide training, and ensure compliance in all aspects of the clinical process

Lead and coordinate timely resolution of any audit findings

Lead and monitor deviations and corrective and preventative actions, ensuring a timely resolution and thorough documentation

Identify, assess, and manage quality risks or compliance concerns proactively and take immediate corrective action as required

Provide leadership and be a resource to staff regarding CLIA, CAP and related regulations and best practices, including maintaining knowledge of applicable regulations, providing consultation to staff regarding regulatory compliance

Qualification

CLIA regulationsCAP regulationsQuality management systemClinical laboratory experienceQuality auditsDocument controlIncident reportingRegulatory complianceCommunication skillsTeam collaborationAttention to detail

Required

Bachelor of Science degree in medical technology, laboratory sciences or scientific disciplines

Minimum 8 years' experience in clinical laboratories performing moderate complexity in vitro diagnostics testing in a CLIA lab

Ability to maintain accurate, organized, detailed and clear work documentation, records/logs, written communication

Demonstrated ability to exercise good judgment and work collaboratively on an interdisciplinary team

Effective verbal and written communication skills and attention to detail with an ability to work in a regulated environment

Preferred

Experience in at home testing, LDT and/or clinical chemistry lab strongly preferred

Certification from professional organization strongly desired. Examples include American Society for Quality (ASQ) / Certified Clinical Laboratory Quality Professional (CCLQP)

Benefits

Annual bonus

Health, dental, vision & mental health insurance

401(k) with company match

Flexible PTO

A monthly $100 wellness stipend

Various other perks

Company

Everlywell

Glassdoor2.6

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.

Founded in 2015

Austin, Texas, USA

201-500 employees

https://www.everlyhealth.com/

H1B Sponsorship

Everlywell has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2021 (1)