Quality Assurance Engineer

Quality Assurance Engineer (Quality Engineer)

Supports quality system processes for Natera’s CLIA laboratories and activities tied to clinical trials, working with senior QA leadership and management to maintain compliance and improve quality.

Responsibilities

• Support internal and external audits, including GCP sponsor reviews, CLIA/CAP, and ISO 13485
• Under limited supervision:
  • Collect and trend quality metrics for clinical trials (per defined parameters or as requested)
  • Provide partnered oversight (with QEII or higher) of CAPAs, deviations, and NCRs related to clinical trials
• Write and/or revise procedures and forms; submit updates to Document Control and support training as needed
• Perform statistical analysis / hypothesis testing (e.g., AQLs) as required
• Support quality system compliance with CLIA, FDA QMSR, ISO 13485, and HIPAA
• Participate in clinical trial-related meetings (as needed)
• Follow standard operating procedures and good documentation practices; partner across functions to review documents and records

Requirements

• B.S. (or equivalent) in science, engineering, or related field
• 2–3 years of work experience in biotech or medical device quality (preferred) or relevant combination
• Audit experience: internal, third-party, and/or regulatory audits
• Basic knowledge of GCLP, ICH-E6, ISO 20916, and CLIA/CAP regulations/standards
• Proficiency with MS Word, Excel, PowerPoint (and general computer skills)
• Strong technical writing, communication, organizational, and planning skills; self-starter

Preferred

• American Society for Quality certification(s)
• Working knowledge of GCLP / ICH-E6 / ISO 20916
• Strong judgment, attention to detail, interpersonal skills, and flexibility to collaborate across multiple projects

Location & Compensation

• Remote (USA)
• Pay range: $94,300–$117,900 USD annually (final compensation varies by candidate factors and office location).