GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is using the power of high-intensity sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop and commercialize pioneering products for the early detection of cancer. The company is located in Menlo Park, California and Hong Kong. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.
The Supplier Quality Engineer will aid in the definition, implementation, and maintenance of the Quality Management System framework, focusing on supplier management, supplier audits, and purchasing controls.
Lead the development, implementation, and maintenance of the supplier quality management program.
Be responsible for the qualification/evaluation of suppliers, performing supplier audits, monitoring of suppliers, supplier improvement/development activities, and supplier corrective action request (SCAR) activities.
Create, maintain, and control approved supplier list and supplier files containing supplier evaluations and supplier notifications.
Monitor, track, and report supplier performance. Work with suppliers on quality issues.
Assist in the development, review, approval and maintenance of supplier requirements/instructions, supplier agreements, and supplier documentation (e.g. quality plan, protocols, reports, FMEAs, etc.)
Be responsible for the overall development and maintenance of policies and standard operating procedures for effective and compliant supplier management program.
Be responsible for providing training on supplier management processes to cross-functional team members.
Collaborate with cross-functional teams to engage suppliers in design/process improvements during the feasibility and development phase of product development.
Lead and identify methods for improving the efficiency and effectiveness of the supplier management program.
Provide guidance and support to the company on supplier management strategies and processes.
Establish and generate metrics to highlight risks and key opportunities for continuous improvement.
Participate in the development, implementation, and maintenance in other areas of the Quality Management System.
Perform other related duties and responsibilities as assigned.
Your Background Should Include:
Bachelor’s Degree in Engineering or related scientific discipline.
5+ years in Quality and/or Supplier Management experience in life sciences industry, preferably in a FDA regulated medical device/IVD environment.
Previous Quality engineering experience and demonstrated use of Quality practices and methods.
Strong working knowledge of FDA QSR/cGMP and ISO regulations.
ISO 13485 lead auditor preferred.
Strong team player with demonstrated track record of success in a cross-functional team environment.
Ability to perform a variety of duties involving critical thinking, analysis, evaluation, and judgement in support of QMS activities.
Ability to influence and be the voice of Quality when working with various groups in the organization.
Effective change management. Ability to bring continuous improvement orientation to the role.
Excellent communication and interpersonal skills.
This position will require between 25-50% travel.
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.
GRAIL is using the power of high-intensity sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology and to develop and commercialize pioneering products for the early detection of cancer. We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to alleviate the global burden of cancer.