Quality Engineer

United StatesRemote

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Responsibilities

Develop and implement quality system documentation (operating procedures, work instructions, specifications etc.)
Conduct or facilitate internal and external audit of product processes and recommend improvements (eg. Notified Body, FDA, HIPAA)
Perform Risk Assessments (e.g. FMEA, FTA, Risk Analysis) with cross-functional team
Monitor and audit laboratory scientist’s process workflow for compliance to HIPAA/ CLIA/ GMP/GLP/GCP and recommend updates
Perform quality assurance for sample testing in support of new products
Perform statistical analysis/hypotheses testing (AQL’s etc)
Implement and monitor Statistical Process Control (SPC)
Maintain Quality systems compliance to CLIA, FDA QSR, ISO 13485, GMP, GCP, GLP and HIPAA
Record and review original test data and follow established company standard operating procedures and good documentation practices
Perform raw data and analytical testing review of in house and contract testing labs

Stay current on applicable regulations and guidance from FDA, ISO13485, CLIA, aaBB, OSHA, EH&S, HIPAA, etc
Must maintain a current status on Natera training requirements.
requirements are a B.S. or equivalent in science, engineering or related field
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
American Society of Quality certifications (CQE, CMQ/OE) preferred
Extensive experience with ISO 14971
Computer skills (MS Word, Excel, PowerPoint, etc.)
Has an ability to be productive and successful in an intense work environment Preferred skills: Hands on
experience with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, Bioinformatics etc.
Demonstrated 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 OUR OPPORTUNITY
Natera™ 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.
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

For more information, visit www.natera.com .
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY.

This position is located at our San Carlos, CA headquarters.
This is an exciting opportunity for an ambitious and dynamic individual to join a fast paced rapidly growing company. PRIMARY RESPONSIBILITIES:
Primary support for compliance activities (management of non-conformances, CAPA, environmental monitoring, process monitoring, audits, complaints investigations)
Participate in CAPA, Deviation, and Non Conformance investigation and reporting
Participate in test method optimization, qualification, and validation as required
Participate in the management of Approved Suppliers
Participate in laboratory maintenance activities, including coordinating and monitoring supply inventories and equipment maintenance and calibration status
This 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.
Independent worker, a self-starter with strong organizational and planning skills
The 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.