{"schemaVersion":"jobsearcher.job.v1","id":"98accc2dd9eeb2d3ff6496c1","url":"https://jobsearcher.com/jobs/98accc2dd9eeb2d3ff6496c1","canonicalUrl":"https://jobsearcher.com/jobs/98accc2dd9eeb2d3ff6496c1","title":"Quality Engineer","description":"Position Summary\nQuality Engineer is supporting early to late stage Laboratory development and In Vitro Diagnostic (IVD) Test. This is an exciting opportunity for an ambitious and dynamic individual to join a fast paced rapidly growing company.\n\nPrimary Responsibilities\n\nCreate, revise and update laboratory, equipment, facility, HIPAA Privacy & Security and quality processes compliance\n\nDevelop and implement quality system documentation (operating procedures, work instructions, specifications etc.)\n\nPrimary support for compliance activities (management of non-conformances, CAPA, environmental monitoring, process monitoring, audits, complaints investigations)\n\nConduct or facilitate internal and external audit of product processes and recommend improvements (eg. Notified Body, FDA, HIPAA)\n\nParticipate in CAPA, Deviation, and Non Conformance investigation and reporting\n\nPerform Risk Assessments (e.g. FMEA, FTA, Risk Analysis) with cross-functional team\n\nMonitor and audit laboratory scientist’s process workflow for compliance to HIPAA/ CLIA/ GMP/GLP/GCP and recommend updates\n\nParticipate in test method optimization, qualification, and validation as required\n\nPerform quality assurance for sample testing in support of new products\n\nPerform statistical analysis/hypotheses testing (AQL’s etc)\n\nImplement and monitor Statistical Process Control (SPC)\n\nMaintain Quality systems compliance to CLIA, FDA QSR, ISO 13485, GMP, GCP, GLP and HIPAA\n\nParticipate in the management of Approved Suppliers\n\nRecord and review original test data and follow established company standard operating procedures and good documentation practices\n\nPerform raw data and analytical testing review of in house and contract testing labs\n\nParticipate in laboratory maintenance activities, including coordinating and monitoring supply inventories and equipment maintenance and calibration status\n\nProvide data policy and security industry expertise and advisory services to projects that involve healthcare data privacy regulations\n\nEstablish recommended HIPAA privacy and security practices\n\nInteract with client data privacy and security resources to define the necessary policies and procedures to comply to the relevant regulations\n\nStay current on applicable regulations and guidance from FDA, ISO13485, CLIA, aaBB, OSHA, EH&S, HIPAA, etc\n\nWork as a member of a fully integrated team\n\nThis role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job.\n\nEmployee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.\n\nMust maintain a current status on Natera training requirements.\n\nOther duties as assigned\n\nQualifications\n\nPosition requirements are a B.S. or equivalent in science, engineering or related field\n\nAt least 2 to 5 years experience or equivalent in Quality process improvement in 21 CFR 820 QSR, SOR 98/282, IVDD, ISO13485, GMP/GLP/GCP/HIPAA environment with medical devices, CLIA laboratory, or Life Sciences industry\n\nAmerican Society of Quality certifications (CQE, CMQ/OE) preferred\n\nExtensive experience with ISO 14971\n\nKnowledge, Skills, And Abilities\n\nComputer skills (MS Word, Excel, PowerPoint, etc.)\n\nGood technical writing and communication skills\n\nIndependent worker, a self-starter with strong organizational and planning skills\n\nHas an ability to be productive and successful in an intense work environment\n\nPreferred Skills\n\nHands on experience with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, Bioinformatics etc.\n\nDemonstrated good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects\n\nOur Opportunity\nNatera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.\n\nThe Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world‑class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.\n\nWhat We Offer\nCompetitive Benefits – Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!\n\nEqual Opportunity Employer\nNatera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.\n\nAll qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.\n\nContact Information\nFor more information, visit www.natera.com.\n\n#J-18808-Ljbffr","company":"Natera","rawCompany":"natera","city":"Boulder","state":"CO","isRemote":false,"isActive":false,"createdAt":"2026-07-18T03:28:05.976Z","occupations":[{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"541380","title":"Testing Laboratories and Services","slug":"testing-laboratories-and-services"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"621511","title":"Medical Laboratories","slug":"medical-laboratories"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer","description":"Position Summary\nQuality Engineer is supporting early to late stage Laboratory development and In Vitro Diagnostic (IVD) Test. This is an exciting opportunity for an ambitious and dynamic individual to join a fast paced rapidly growing company.\n\nPrimary Responsibilities\n\nCreate, revise and update laboratory, equipment, facility, HIPAA Privacy & Security and quality processes compliance\n\nDevelop and implement quality system documentation (operating procedures, work instructions, specifications etc.)\n\nPrimary support for compliance activities (management of non-conformances, CAPA, environmental monitoring, process monitoring, audits, complaints investigations)\n\nConduct or facilitate internal and external audit of product processes and recommend improvements (eg. Notified Body, FDA, HIPAA)\n\nParticipate in CAPA, Deviation, and Non Conformance investigation and reporting\n\nPerform Risk Assessments (e.g. FMEA, FTA, Risk Analysis) with cross-functional team\n\nMonitor and audit laboratory scientist’s process workflow for compliance to HIPAA/ CLIA/ GMP/GLP/GCP and recommend updates\n\nParticipate in test method optimization, qualification, and validation as required\n\nPerform quality assurance for sample testing in support of new products\n\nPerform statistical analysis/hypotheses testing (AQL’s etc)\n\nImplement and monitor Statistical Process Control (SPC)\n\nMaintain Quality systems compliance to CLIA, FDA QSR, ISO 13485, GMP, GCP, GLP and HIPAA\n\nParticipate in the management of Approved Suppliers\n\nRecord and review original test data and follow established company standard operating procedures and good documentation practices\n\nPerform raw data and analytical testing review of in house and contract testing labs\n\nParticipate in laboratory maintenance activities, including coordinating and monitoring supply inventories and equipment maintenance and calibration status\n\nProvide data policy and security industry expertise and advisory services to projects that involve healthcare data privacy regulations\n\nEstablish recommended HIPAA privacy and security practices\n\nInteract with client data privacy and security resources to define the necessary policies and procedures to comply to the relevant regulations\n\nStay current on applicable regulations and guidance from FDA, ISO13485, CLIA, aaBB, OSHA, EH&S, HIPAA, etc\n\nWork as a member of a fully integrated team\n\nThis role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job.\n\nEmployee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.\n\nMust maintain a current status on Natera training requirements.\n\nOther duties as assigned\n\nQualifications\n\nPosition requirements are a B.S. or equivalent in science, engineering or related field\n\nAt least 2 to 5 years experience or equivalent in Quality process improvement in 21 CFR 820 QSR, SOR 98/282, IVDD, ISO13485, GMP/GLP/GCP/HIPAA environment with medical devices, CLIA laboratory, or Life Sciences industry\n\nAmerican Society of Quality certifications (CQE, CMQ/OE) preferred\n\nExtensive experience with ISO 14971\n\nKnowledge, Skills, And Abilities\n\nComputer skills (MS Word, Excel, PowerPoint, etc.)\n\nGood technical writing and communication skills\n\nIndependent worker, a self-starter with strong organizational and planning skills\n\nHas an ability to be productive and successful in an intense work environment\n\nPreferred Skills\n\nHands on experience with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, Bioinformatics etc.\n\nDemonstrated good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects\n\nOur Opportunity\nNatera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.\n\nThe Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world‑class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.\n\nWhat We Offer\nCompetitive Benefits – Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!\n\nEqual Opportunity Employer\nNatera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.\n\nAll qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.\n\nContact Information\nFor more information, visit www.natera.com.\n\n#J-18808-Ljbffr","datePosted":"2026-07-18T03:28:05.976Z","dateModified":"2026-07-18T03:28:05.976Z","hiringOrganization":{"@type":"Organization","name":"Natera","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Boulder","addressRegion":"CO","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"98accc2dd9eeb2d3ff6496c1"},"url":"https://jobsearcher.com/jobs/98accc2dd9eeb2d3ff6496c1"}}