GRAIL

Senior Quality Process Engineer

GRAIL

full-time

Posted on:

Location Type: Remote

Location: California • United States

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Salary

💰 $91,000 - $114,000 per year

Job Level

Senior

About the role

  • executing, maintaining, and improving elements of GRAIL’s quality management system (QMS)
  • supporting GRAIL’s Quality Management System for medical device processes
  • interacting with departments across the organization including Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Quality Assurance, Supply Chain, Manufacturing, and Research & Development
  • leading and conducting Internal Audits
  • supporting Quality Management Review (QMR)
  • generating Quality Indices metrics
  • evolving standards watch and management
  • managing the Quality Planning process
  • supporting efforts to obtain and maintain licenses, accreditations, and certifications
  • contributing to a positive environment of accountability and performance excellence

Requirements

  • Bachelor’s degree in science, engineering, or other technical area.
  • Minimum of 5 years of experience working within a clinical laboratory (high complexity CLIA/CAP environment) or related (e.g., IVD medical device, pharma, etc.) quality management system.
  • Experience working with applicable regulations and standards including CAP/CLIA, New York State Department of Health, ISO 13485, ISO 15189, and other applicable industry requirements.
  • Experience supporting regulatory inspections/audits and responding to findings.
  • Excellent written and verbal communication skills.
  • Ability to comprehend and interpret technical information.
  • Master’s degree in a related technical area, or MBA a plus.
  • Next Generation Sequencing (NGS) experience a plus.
  • ASQ Certified Quality Auditor, Certified Quality Engineer, or similar a plus.
Benefits
  • flexible time-off or vacation
  • a 401(k) retirement plan with employer match
  • medical, dental, and vision coverage
  • carefully selected mindfulness programs
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality management systeminternal auditsquality indices metricsquality planningnext generation sequencing
Soft Skills
communication skillsaccountabilityperformance excellence
Certifications
ASQ Certified Quality AuditorCertified Quality Engineer