POSITION SUMMARY:
Quality Engineer supports the quality system processes of the Natera CLIA laboratories and activities associated with clinical trials. The QE works with senior level QE’s and management to address GCP compliance, supplier issues, non conformances and corrective actions that impact the CLIA laboratory operations.
PRIMARY RESPONSIBILITIES:
Support internal and external audits (GCP sponsor, CLIA/CAP, ISO 13485)
Under limited supervision, collect and trend quality metrics for clinical trials per pre-defined parameters and/or upon request; provide partnered oversight (with QEII or higher) of CAPAs, deviations, and NCRs associated with clinical trials;
Write/revise procedures and forms; submit to Document Control and assist with training as needed
Perform statistical analysis/hypotheses testing (AQL’s etc) as required
Support Quality systems compliance to CLIA, FDA QMSR, ISO 13485, and HIPAA
Participate in clinical trial related meetings (as needed),
Follow established company standard operating procedures and good documentation practices
Partner across functions to provide review of documents and records;
Expands skills as QA professional through execution of duties, independent learning, and training courses.
Enhances knowledge in clinical regulations and guidelines (GCLP, ICH E6, CFR's, ISO 20916, IVDR).
Other duties as assigned
QUALIFICATIONS:
Position requirements are a B.S. or equivalent in science, engineering or related field
2-3 years of work experience in Biotech industry, medical device industry preferred or a relevant combination of skills, education, and experience in Quality Assurance
Audit experience – internal audits, third party audits and/or regulatory audits
American Society of Quality certifications preferred
KNOWLEDGE, SKILLS, AND ABILITIES:
Basic Knowledge of GCLP, ICH-E6 and ISO 20916, CLIA/CAP regulations and standards, ISO 13485
Computer skills (MS Word, Excel, PowerPoint, etc.)
Good technical writing and communication skills
Independent worker, a self-starter with strong organizational and planning skills
Has an ability to be productive and successful in an intense work environment
Preferred skills:American Society of Quality certifications preferred
Working knowledge of GCLP, ICH-E6 and ISO 20916 preferred
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.
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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