Quality Engineering Manage

Quality Engineer is supporting early to late stage Laboratory development and In Vitro Diagnostic (IVD) Test. Create, revise and update laboratory, equipment, facility, HIPAA Privacy & Security and quality processes compliance

Develop and implement quality system documentation (operating procedures, work instructions, specifications etc.)

Primary support for compliance activities (management of non-conformances, CAPA, environmental monitoring, process monitoring, audits, complaints investigations)

Conduct or facilitate internal and external audit of product processes and recommend improvements (eg. Perform Risk Assessments (e.g. FMEA, FTA, Risk Analysis) with cross-functional team

Perform quality assurance for sample testing in support of new products

Perform statistical analysis/hypotheses testing (AQL’s etc)

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

Participate in laboratory maintenance activities, including coordinating and monitoring supply inventories and equipment maintenance and calibration status

Provide data policy and security industry expertise and advisory services to projects that involve healthcare data privacy regulations

Interact with client data privacy and security resources to define the necessary policies and procedures to comply to the relevant regulations

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.

Employee 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.

Must maintain a current status on Natera training requirements.

S. or equivalent in science, engineering or related field

At 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

American Society of Quality certifications (CQE, CMQ/OE) preferred

Computer skills (MS Word, Excel, PowerPoint, etc.)

Good technical writing and communication skills

Independent worker, a self-starter with strong organizational and planning 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

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.

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. Competitive 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. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All 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.