Staff Quality Engineer, CAPA Program #4693 at Grailbio

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. For more information, please visit grail.com The Staff Quality Process Engineer serves as a key technical expert responsible for leading quality process engineering activities and initiatives that ensure compliance with internal standards, customer expectations, and regulatory requirements. This role applies deep technical knowledge to solve complex quality challenges, lead cross-functional projects, and drive continuous improvement. The position provides technical leadership within the quality function and plays a critical role in shaping processes that enhance product reliability and operational excellence. 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. Responsibilities: • Lead and execute high-impact quality engineering projects that improve product quality, reliability, and compliance. • Develop, implement, and maintain advanced quality control processes, statistical methods, and risk management practices. • Lead complex root cause investigations and corrective/preventive action plans, ensuring systemic issues are addressed. • Partner with engineering, manufacturing, and supply chain teams to design and optimize processes for quality and efficiency. • Provide technical expertise in measurement system analysis, process validation, and statistical process control. • Serve as a subject matter expert during internal audits, regulatory inspections, and customer quality assessments. • Prepare and present quality metrics, trend analyses, and recommendations to senior leadership. • Mentor and coach junior and mid-level engineers, promoting knowledge sharing and development across the team. • These job duties are a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion. Responsibilities: • Bachelor's degree in Engineering, Quality Assurance, Industrial Technology, or a related field with 8–12 years of relevant work experience in quality engineering, process engineering, or manufacturing; OR Master's degree with 5–8 years of relevant experience; OR PhD with 2–5 years of relevant experience. • Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include: • GMP quality management systems (e.g. ISO 13485) • Risk assessment frameworks (e.g. ISO 14971) • Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189) • Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) • Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56) Required Qulifications: • Bachelor's degree in Engineering, Quality Assurance, Industrial Technology, or a related field with 8–12 years of relevant work experience in quality engineering, process engineering, or manufacturing; OR Master's degree with 5–8 years of relevant experience; OR PhD with 2–5 years of relevant experience. • Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include: • GMP quality management systems (e.g. ISO 13485) • Risk assessment frameworks (e.g. ISO 14971) • Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189) • Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) • Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56) Preferred Qualifications: • Advanced expertise in quality systems, methodologies, and regulatory requirements (ISO 9001, GMP, Six Sigma, etc.). • Proven ability to lead cross-functional initiatives and drive measurable process improvements. • Strong knowledge of advanced quality engineering tools (FMEA, MSA, DOE, SPC, Lean Six Sigma). • Excellent analytical and statistical problem-solving skills. • Strong leadership and mentoring skills, with the ability to influence across functions and levels. • Exceptional communication and presentation skills, including the ability to convey technical concepts to executive leadership. • Proficiency in quality and statistical analysis software (e.g., Minitab, JMP, or similar). Physical Demands and Environment: • Work is performed in office, laboratory, and production environments. • Frequent engagement with production processes, inspection systems, and testing equipment. • May involve occasional lifting of up to 25 lbs. and extended standing or walking in manufacturing areas. • PPE such as safety glasses, gloves, or cleanroom attire required depending on assignment. • Standard weekday schedule, with flexibility for extended hours during audits, inspections, or urgent quality issues. The expected, full-time, annual base pay scale for this position is $118K - $147K for Menlo Park, CA.  Actual base pay will consider skills, experience, and location. This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidate’s qualifications. Employees in this role are also eligible for GRAIL’s comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, , or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at [Upgrade to PRO to see contact] if you require an accommodation to apply for an open position. GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!