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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.
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.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysishypotheses testingCAPADeviationChange RequestsNonconformance investigationprocedure writinggood documentation practicesquality systems compliancemanufacturing/QC batch records
Certifications
B.S. in scienceB.S. in engineeringCQE