Associate Quality Engineer

Requirements

• 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
• 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
• OUR OPPORTUNITY

Benefits

Additional Information

POSITION SUMMARY: Associate Quality Engineer (AQE) supports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software. The AQE 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. 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 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

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