Quality Engineer 2
Quality Engineer 2
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Job Description
POSITION SUMMARY:
Quality Engineer II supports the quality system processes of the Natera CLIA laboratories and activities associated with commercial operations and product lifecycles. The QE II role has combined responsibilities that include management of quality events related to onmarket products. They will also work to assist with implementation of postmarket product improvements and new product development. This individual will work closely with crossfunctional teams to implement the requirements of Nateras Quality Management System across a wide range of projects.
PRIMARY RESPONSIBILITIES:
- 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
- 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
- Support postmarket product improvement
- Support the development of new products
- Other duties as assigned
QUALIFICATIONS:
- Must have clinical laboratory experience in a CAP/CLIA environment
- Position requirements are a B.S. or equivalent in biology chemistry 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 NYS IVDR CLSI ISO medical device applicable standardsetc.
- Computer skills (MS Word Excel PowerPoint etc.
- Good technical writing and communication skills
- Independent worker a selfstarter with strong organizational and planning skills
- 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
Location:
- Hybrid with 2550 onsite preference
- San Carlos CA preferred
- Austin TX considered
San Carlos CA
$77000 $96400 USD
Austin TX
$65400 $81700 USD
OUR OPPORTUNITY
Natera is a global leader in cellfree DNA (cfDNA) testing dedicated to oncology womens 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 worldclass institutions who care deeply for our work and each other. When you join Natera youll work hard and grow quickly. Working alongside the elite of the industry youll 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 .
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: be advised that Natera will reach out to candidates with a @ 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
Employment Type
Full Time
