SENIOR QUALITY ENGINEER
SENIOR QUALITY ENGINEER
CLIA Quality and Operations
GRAIL, Inc., is a discovery-stage life sciences company that is developing differentiated platforms for the early detection of cancer. GRAIL’s research programs combine approaches to ultra-deep sequencing of circulating, cell-free nucleic acids with innovative clinical programs of the scale and quality required to generate strong scientific and clinical evidence of their utility. GRAIL’s software and computational biology efforts are commensurate to the size and complexity of the resulting data sets. We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to dramatically reduce the global burden of cancer.
The Senior Quality Engineer will participate in the definition, implementation and maintenance of the Quality framework and processes required to robustly deliver GRAIL’s laboratory developed tests in its Clinical Laboratory.
TASKS AND RESPONSIBILITIES
- Lead and participate in activities to establish and maintain GRAIL’s quality management system including internal audit, document control, training, non-conformance handling, corrective and preventive action, process monitoring and improvement, design control, risk management and supplier quality activities.
- Contribute to new product development projects as a Quality team member and communicate activities to the extended members of the Quality team.
- Provide Quality guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities.
- Lead and participate on cross-functional teams responsible for securing CLIA certification, CAP accreditation, and state licensure for the GRAIL Clinical Laboratory, including interfacing with external regulatory agencies.
- Maintain knowledge of the evolving regulatory landscape for LDTs and NGS-based tests.
- Perform other related duties and responsibilities as assigned.
- Bachelor’s Degree in Biomedical Laboratory Science, Engineering or related field in Technical Discipline.
- >5 years of Quality experience in the life sciences industry, preferably in a high-complexity CLIA or FDA regulated environment.
- Previous Quality engineering experience and demonstrated use of Quality practices and methods.
- Working knowledge of CLIA/CAP, ISO and/or FDA regulations and best practices for conducting LDTs for clinical application.
- First-hand experience and success in establishing de novo quality systems infrastructure.
- Strong team player with demonstrated track record of success in a cross-functional team environment.
- Ability to influence and be the voice of Quality when dealing with multiple groups in the organization.
- Manages change well and adopts a continuous improvement orientation to the role.
- Excellent communication and interpersonal skills.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.