Quality Technician II

Overview

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

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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 role is based at our Durham, North Carolina, office. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.

• Support medical device Quality Engineering operations accordance with GRAIL’s quality management system and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, and related regulations and standards.
• Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
• 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.
• dentify and evaluate deficiencies and improvement opportunities, working cross-functionally to resolve and improve on existing processes.
• Support DHR review process
• Support NCR, DAR & CAPA process
• Support change management workflows, and acceptance activities including incoming and finished product release.
• Support audits and inspections as needed
• Support other project teams (including clinical laboratory) as determined by management.
• These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

• Associate Degree in science, engineering, or other technical area.
• Minimum of 3 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.

• Primarily desk-based work with extended periods of computer use.
• Frequent typing and screen interaction
  
  Occasional light lifting up to 10 Ibs.
• Quiet to moderate noise level in…