Overview
Quality Engineer Jobs in Austin, Texas, USA at Tbwa Chiat/Day Inc
Position: Quality Engineer 2
Quality Engineer II supports the quality system processes of the Natera CLIA laboratories and activities associated with commercial operations and product life cycles. The QE II role has combined responsibilities that include management of quality events related to on-market products. They will also work to assist with implementation of post-market product improvements and new product development. This individual will work closely with cross-functional teams to implement the requirements of Natera’s 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 post-market 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 standards (13485, 14971, 9001 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:
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 25-50% onsite preference
Salary:
$65,400 – $81,700 USD
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.
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!
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.
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Title: Quality Engineer
Company: Tbwa Chiat/Day Inc
Location: Austin, Texas, USA
Category: Healthcare, Quality Assurance – QA/QC
