GRAIL-posted 3 months ago
$82,000 - $96,000/Yr
Full-time • Mid Level
Durham, NC
1,001-5,000 employees

This position is a key individual contributor in the Quality Operations organization, responsible for executing, maintaining, supporting, and improving GRAIL’s quality management system (QMS). This role’s focus is on the in vitro diagnostic medical device processes, supporting the clinical laboratory processes as needed with consideration for the single GRAIL QMS. This position interacts with departments throughout the organization including but not limited to all-Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Affairs, Supply Chain, Manufacturing, and Research & Development. The person in this role consistently applies critical thinking skills and good judgment to solve complex problems, effectively communicating status and recommendations to management. This position requires regular on-site presence (5 days a week).

  • Support medical device Quality Engineering operations through expert interpretation, establishment, and execution of quality engineering concepts and principles in accordance with GRAIL’s quality management system and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, and related regulations and standards.
  • Use proactive, creative problem-solving to contribute to development of concepts and principles to achieve goals and objectives.
  • Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
  • Solve extremely complex problems in which analysis of situations or data requires an in-depth evaluation and assessment of intangible variables.
  • Exercise excellent judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
  • Act independently to determine methods and procedures to successfully complete assignments.
  • Structure day-to-day work autonomously, effectively communicating status and issues with management.
  • Identify and evaluate deficiencies and improvement opportunities, working cross-functionally to resolve and improve on existing processes.
  • Support qualifications & validation activities (IQ/OQ/PQ/TMV).
  • Support DHR review process.
  • Support NCR, DAR & CAPA process.
  • Support change management workflows, and acceptance activities including incoming and finished product release.
  • Support Quality Management Review (QMR), Quality Indices metrics generation and review, audits, and on-market Design History File and Risk Management File updates.
  • Support audits and inspections as needed.
  • Support other project teams (including clinical laboratory) as determined by management.
  • Bachelor's degree in science, engineering, or other technical area.
  • Minimum of 5 years of experience working within a medical device, pharmaceutical, or biotech quality management system.
  • Experience working with in vitro diagnostic medical device regulations and standards including ISO 13485:2016, 21 CFR 820, IVDR, and other applicable industry requirements.
  • Strong written and verbal communication skills.
  • Ability to comprehend and interpret technical information.
  • Flexible time-off
  • 401k with a company match
  • Medical, dental, vision plans
  • Mindfulness offerings
  • Annual bonus plan tied to company and individual performance
  • Long-term incentive plan
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