Quality Engineer - CLIA
- United States
Quality Engineer 2 supports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software. The QE II works with senior-level QE's to address supplier issues, nonconformances and corrective actions that impact the CLIA laboratory operations. This position may also represent QA on product development projects.
POSITION LOCATION: Austin, TX, San Carlos, CA or Remote, USA
- Support internal and external audits (CLIA/CAP, ISO 13485, customer)
- Support CAPA, Deviation, Change Requests and Nonconformance investigation and reporting
- Write/revise procedures and forms
- Perform statistical analysis/hypotheses testing (AQL's etc) as required
- Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA
- Participate in the management of Approved Suppliers
- Follow established company standard operating procedures and good documentation practices
- Review manufacturing/QC batch records
- Other duties as assigned
- Position requirements are a B.S. or equivalent in science, engineering or related field
- At least 4 years of experience in medical diagnostic, CLIA laboratory, or Life Sciences industry; 2 years experience working in a Quality role preferred
- Audit experience - internal audits, third party audits and/or regulatory audits
- American Society of Quality certifications (CQE) preferred
KNOWLEDGE, SKILLS, AND ABILITIES:
- Knowledge of CLIA/CAP regulations, ISO 13485 standard and/or FDA QSRs (21 CFR 820)
- 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
- 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
PHYSICAL DEMANDS & WORK ENVIRONMENT:
- Duties typically performed in an office setting
- Must be able to sit or stand for long periods of time
Travel required for this position:
- No ☒ or Yes ☐ : If yes state anticipated percent for travel: N/A
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.
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. Healthy catered lunches, Premium snacks and beverages, Onsite gym with cardio and weight-training equipment, Game room with satellite TV, Onsite dry cleaning and alteration service with pick-up and delivery, Employee-organized sport leagues, Happy hours and BBQs, 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.
POSITION LOCATION: NOTE THAT THIS POSITION IS REMOTE AND CAN WORK FROM ANYWHERE IN THE US
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