Grail’s mission is to detect cancer early, when it can be cured
Staff Supplier Quality Engineer
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation 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 its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA 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. For more information, please visit www.grail.com.
The Senior/Staff Supplier Quality Engineer plays an integral role in supporting quality activities related to Supplier Management in accordance with FDA, ISO, and other IVD regulations. This individual also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation and ISO 13485 and CLIA, CAP, and applicable state requirements.
- Own all aspects of global supplier relationships and technical processes that impact the Cost of Quality (COQ) to GRAIL’s products.
- You'll be tasked with measuring, preventing, reacting, and enforcing key processes and procedures to manage suppliers reactively and proactively with minimal supervision.
- Ensure the performance of all required supplier maintenance activities meet current quality needs and to improve supplier performance and productivity.
- Strategically plan, develop, promote, and implement programs designed to improve supplier performance and productivity and reduce overall costs.
- Plans organize and report supplier performance to provide essential information to the management team.
- Participate in the supplier selection process and perform supplier audits to evaluate supplier capabilities, quality systems, processes, and services.
- Perform validations and qualifications of suppliers to qualify the manufacturing process and overall quality of part/component manufacturing.
- Assists incoming quality and participates in the MRB process to resolve internal and external quality audit findings related to purchased products.
- Own and relentlessly drive supplier root cause analysis and corrective actions to prevent the recurrence of quality issues.
- Provide statistical support by creating supplier-related metrics for tracking vendor performance and identifying opportunities for supply chain improvements.
- Ensure primary suppliers have adequate control plans, schedules, and resources to make continued improvements to the incoming quality of supplied products.
- Works with Engineering and Quality to ensure that incoming product specifications contain and clearly communicate the requirements needed to ensure supplied products are acceptable for manufacturing and assist in developing inspection methods and improving sampling plans for new materials and components.
- Identifies non-conformance trends; develops and administers technical investigations and corrective action programs to resolve recurring quality problems.
- Provide technical assistance to suppliers/other resources performing qualification/validation testing.
- Uses Quality Engineering tools (i.e. FMEA) to solve complex problems.
- Create and maintain a plan to help with the development of direct reports and their professional growth.
Your Background Should Include:
- Bachelor’s Degree in Engineering or Science field.
- 5 to 8 years’ experience in a QMS environment with 2 to 4 years working as a supplier quality engineer.
- 5+ years of supplier quality experience in the Life Sciences Industry, with prior experience in an FDA regulated environment.
- Have a strong background in applying statistical tools for process and product development and control (i.e. Gage R&R, Process Capability, Control Plans, SPC, Process Failure Mode Effects Analysis (PFMEA), and Design of Experiments (DOEs)).
- Working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CRF 820, ISO 13485, IVDD, and other applicable quality and regulatory standards).
- Experience in all aspects of supplier quality, including supplier assessments/audits, maintaining a supplier evaluation program, supplier corrective actions, and supplier process changes.
- Effective verbal and written communication skills and the ability to share and receive information from all levels of the organization throughout various departments.
- Travel will be required up to 25% of the time, both domestically and internationally.
- Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.
Complete health coverage
Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.
Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.
On site amenities
Stay healthy, happy and productive with our gym facilities, and daily catered lunches and snacks for all.
Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.
We offer competitive salaries and savings plans to provide peace of mind for long-term financial planning.
GRAIL at a glance
GRAIL focuses on Biotechnology, Life Sciences, Healthcare, Diagnostics, and Medical Technologies. Their company has offices in Menlo Park. They have a large team that's between 201-500 employees. To date, GRAIL has raised $3.605B of funding; their latest round was closed on May 2020.