GRAIL · 13 hours ago
Senior Quality Systems Engineer # 4465
Menlo Park, CA
Full-time
Hybrid
Mid, Senior Level
$109K/yr - $136K/yr
5+ years expGRAIL is a healthcare company focused on pioneering new technologies for early cancer detection. The Senior Quality Systems Engineer will support the maintenance and improvement of GRAIL’s Quality Management Systems, ensuring compliance with various regulations while working collaboratively across teams.
BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Ensure compliance with company processes and procedures, as well as applicable FDA QSR, IVDD/IVDR, ISO, CAP/CLIA, and NYS regulations and/or guidelines
Responsible for the oversight and continuous improvement of efficient, effective, and compliant processes supporting GRAIL’s electronic Quality Management System (eQMS) and Learning Management System
Lead continuous quality system process improvements, workflow implementations, and system configurations associated with the Change Management program, encompassing Document Control, Change Control, and Quality Training
Create and lead educational presentations on change management programs (new hire, process updates, etc.)Maintain controlled documents, track document change management processes, and edit documents to ensure formatting, legibility, completeness, and adherence to GRAIL’s controlled templates, procedures, and other relevant processes
Coordinate the review, approval, and archival of GRAIL’s controlled documents in accordance with strict timelines as well as internal policies and regulations
Collaborate and provide mentorship to change owners, approvers, and cross-functional owners, ensuring effective implementation of change. Call out areas of non-compliance, risk and/or potential improvement to management and develop plans for appropriate action to address causes of deficiencies
Respond to all inbound document-related inquiries and maintain effective cross-functional team communications to advance GRAIL’s quality activities and promote standard methodologies
Address, respond-to, and complete NCRs, CAPAs, and Internal/External Audit Findings associated with document management needs and gaps. Generate data for key performance indicators (KPIs)/metrics for management reviews
Provide document control support for internal and external audits and inspections
Assist the Quality Systems Software Business Owner/SME with validation and configuration maintenance/improvements, including testing for system implementations and updating documents (SOPs, reports, protocols, specifications, etc.), as well as documenting, assessing, and resolving feedback to improve the end user experience, as needed
Cultivate positive relationships with key partners, leadership team members, and other cross-functional partners throughout GRAIL, including third-party vendors/consultants
Assess unusual circumstances and use sophisticated analytical and problem solving techniques to identify causes. Resolve a wide range of issues in creative but compliant ways and suggest variations in approach
Qualification
Required
Bachelor's degree and experience developing, implementing and leading quality or regulatory activities or equivalent knowledge or experience
5+ years of experience performing a quality management function, preferably with experience in Document and Records Management
Working knowledge and understanding of regulations and standards, including but not limited to QSR, ISO 13485 Quality System, CAP/CLIA, NYS, ISO 15189, ISO 13485, IVDR, and other applicable industry requirements
Experience using an eDMS required; Veeva Vault highly preferred
Proven ability to efficiently manage workload under tight deadlines and pressure in a composed manner
Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness
Requires exceptional interpersonal, verbal, and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced environment with minimal direction and able to be flexible
Demonstrated project management experience developing processes and leading their implementation in a cross-functional environment
Ability to adapt to changes in the work environment; manages competing demands; changes approach or method to best fit the situation
Ability to deal with frequent change, delays, or unexpected events
Experience with auditing and experience representing and responding to regulatory agency audits
Preferred
Proficiency with standard office software applications including Microsoft Office, Google Suite, Jira, and Zoom
Working experience in technical writing is appreciated
Benefits
Flexible time-off or vacation
A 401(k) retirement plan with employer match
Medical, dental, and vision coverage
Carefully selected mindfulness programs
Company
GRAIL
Grail is a healthcare company that develops pan-cancer screening tests designed to detect cancers at an early stage.
1001-5000 employees
H1B Sponsorship
GRAIL has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (26)
2023 (23)
2022 (46)
2021 (25)
2020 (9)
Funding
Current Stage
Public CompanyTotal Funding
$2.44BKey Investors
ARCH Venture PartnersIllumina
2025-10-20Post Ipo Equity· $325M
2025-10-16Post Ipo Equity· $110M
2024-06-13IPO
Leadership Team
Satnam Alag
Senior Vice President Software Engineering and Chief Security Officer
Joshua J. Ofman
President
Recent News
2026-01-14
2026-01-13
2026-01-09
Company data provided by crunchbase