Senior Process Engineer - Compliance #4968

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

Lead and own quality management system (QMS) activities, including change controls, document control, SOP revisions, deviations/nonconformances (NCs), and corrective and preventive actions (CAPAs). Develop and maintain work instructions, guidelines, verifications, and standard operating procedures. Independently investigate and resolve process deviations, applying root cause analysis and implementing effective corrective and preventive actions. Support internal audits, external inspections, and regulatory assessments; prepare documentation, evidence packages, and responses to audit observations. Partner cross-functionally with Quality Assurance, Regulatory Affairs, Engineering Operations, Validation, and Clinical Operations leadership to implement and sustain compliant processes. Identify process gaps, compliance risks, and operational inefficiencies; recommend and implement sustainable corrective actions and process improvements. Mentor and train personnel on workflows, quality processes, and regulatory expectations. Provide technical guidance and support to engineers and technicians to promote process understanding and standardization. Prepare and present technical reports, proposals, and recommendations to management for process enhancements and cost savings. Develop training compliance processes, including assignment, completion tracking, and on the job training assessments. 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.

Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, or related field) with 5+ years of relevant experience, or Master’s degree with 3+ years of relevant experience, or PhD with 2+ 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) 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) Experience supporting audits, inspections, and regulatory readiness activities. Proven ability to manage multiple priorities and drive projects to completion in a fast-paced regulated environment.

Strong working knowledge of quality management systems (QMS) and regulated laboratory/manufacturing operations. Expertise in change control, CAPA management, deviation/nonconformance investigations, and document control processes. Strong analytical and organizational skills with the ability to manage metrics, trend data, and compliance reporting. Excellent written and verbal communication skills, including technical writing and audit documentation. Strong collaboration and stakeholder management skills across cross-functional teams. Process improvement mindset with demonstrated success driving operational and quality improvements. Experience in executing within computerized maintenance/calibration equipment management systems. Excellent communication skills to influence and collaborate across departments and present technical findings. Leadership skills to mentor junior engineers and lead cross-functional teams. Strong project management and organizational skills; able to manage multiple workstreams with competing priorities

Work performed in office, laboratory, and manufacturing production environments. Regular interaction with production equipment, requiring PPE such as safety glasses, gloves, lab coats, or cleanroom garments. Frequent standing, walking, and occasional lifting of 25–30 lbs. Exposure to chemicals, noise, and temperature variations in production areas. May require flexible hours, overtime, or weekend work to support production or project deadlines.