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Quality Engineer
NateraAssociate Quality Engineer supporting quality system processes and quality compliance at Natera's CLIA laboratories. Examining supplier issues, nonconformances and corrective actions impacting laboratory operations.
ATS Keywords
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Hard Skills
statistical analysishypotheses testingCAPADeviationChange RequestsNonconformance investigationprocedure writinggood documentation practicesquality systems compliancemanufacturing/QC batch records
Certifications & Qualifications
B.S. in scienceB.S. in engineeringCQE
Industry Keywords
CLIACAPISO 13485FDA QSRHIPAAmedical diagnosticCLIA laboratoryLife Sciencesinternal auditsthird party audits
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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 in a Quality role preferred.
- Audit experience – internal audits, third party audits and/or regulatory audits.
- American Society of Quality certifications (CQE) preferred.
Benefits
Comp & perks- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Free testing for employees and their immediate families.
- Fertility care benefits.
- Pregnancy and baby bonding leave.
- 401k benefits.
- Commuter benefits.
- Generous employee referral program.