POSITION SUMMARY
Quality Engineer IV: supports clinical trials in accordance with approved diagnostic protocols, quality system procedures, regulations, and standards. This position will be the QA representative on various Natera-sponsored studies and studies for companion diagnostics.
PRIMARY RESPONSIBILITIES
• May supervise one or more quality engineers for short-term projects or process improvement efforts
• Solve quality challenges and objectives in an effective, compliant, and creative manner with minimal management oversight.
• Is the Quality Representative on studies across Natera’s portfolio. Studies may include those for companion diagnostic and in vitro diagnostic studies in accordance with 21 CFR part 812, 21 CFR part 50, 21 CFR Part 54, 21 CFR Part 56, ISO 20916, and IVDR (EU) 2017/746 and ICH-E6(R2).
•Attend and participate in sponsor-related trial meetings when required
• Provide guidance to the project team on risk management, GCP, and quality system processes.
• Conduct or facilitate internal and external audits of product processes and recommend improvements (e.g. Notified Body, FDA, HIPAA).
• Participate in CAPA, Planned Deviation, and Non-Conformance and Audit Corrective Action investigation and reporting.
• Maintain Quality systems compliance with CLIA, and CAP. FDA QSR, ISO 13485, GMP, GCP, GLP, and HIPAA.
• Report on study-related metrics.
• Other duties as assigned.
QUALIFICATIONS
B.S. in science, engineering, related field, or equivalent.
8 years of experience in a Quality role with experience in medical devices/diagnostics, CLIA laboratory, or Life Sciences industry
American Society of Quality certifications (CQE, CMQ/OE) or Six Sigma preferred.
KNOWLEDGE, SKILLS, AND ABILITIES
Strong knowledge of Quality Management Systems and the various processes within the system, ICH-E6(R2), 21CFR Part 11, GCP regulations under 21 CFR
Computer skills (MS Word, Excel, PowerPoint, etc.).
Good technical writing and communication skills.
Independent worker, a self-starter with strong organizational and planning skills.
Ability to be productive and successful in an intense work environment.
Experience with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, Bioinformatics, etc. is a plus.
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 preferred.
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.
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. 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.
WHAT WE OFFER
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. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera 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.
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.
If you are based in California, we encourage you to read this important information for California residents.
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. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
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