Job Overview
Location
Durham, NC
Job Type
Full-time
Category
Software Engineering
Date Posted
June 3, 2026
Full Job Description
đź“‹ Description
- • Lead the design, implementation, and continuous improvement of post-market surveillance systems for GRAIL’s early cancer detection technologies, ensuring compliance with global regulatory requirements including FDA, EU MDR, and ISO 13485.
- • Own the end-to-end complaint handling process for customer and healthcare provider reports related to GRAIL’s liquid biopsy tests, including intake, triage, investigation, root cause analysis, and timely reporting to regulatory authorities.
- • Collaborate with cross-functional teams including Clinical, Laboratory Operations, Bioinformatics, Regulatory Affairs, and Quality Systems to investigate complaints and implement corrective and preventive actions (CAPAs).
- • Develop and maintain standardized procedures, work instructions, and training materials for complaint handling and post-market surveillance activities to ensure consistency and audit readiness.
- • Monitor and analyze complaint trends and adverse event data to identify potential product issues, initiate risk assessments, and support proactive product safety initiatives.
- • Serve as the primary point of contact for internal and external audits related to complaint handling and post-market surveillance, ensuring all documentation meets regulatory expectations.
- • Interface with global regulatory agencies and external partners to submit required safety reports, including Medical Device Reports (MDRs) and Field Safety Corrective Actions (FSCAs), within mandated timelines.
- • Utilize electronic quality management systems (eQMS) to track, manage, and report complaints and adverse events with full audit trail integrity.
- • Participate in product development lifecycle reviews to embed post-market surveillance requirements early in design and validation phases.
- • Maintain up-to-date knowledge of evolving global regulations for medical device post-market surveillance and ensure internal processes remain compliant.
- • Train and mentor junior quality engineers and support staff on complaint handling protocols, regulatory expectations, and quality system requirements.
- • Prepare and present quality metrics and performance reports to senior leadership on complaint volume, resolution times, trend analysis, and regulatory compliance status.
- • Support investigations into manufacturing or analytical process deviations that may contribute to customer complaints or product performance issues.
- • Ensure all complaint-related documentation is complete, accurate, and archived in accordance with retention policies and regulatory standards.
- • Contribute to the continuous improvement of GRAIL’s quality management system by identifying inefficiencies and proposing scalable solutions for complaint handling workflows.
🎯 Requirements
- • Bachelor’s degree in Life Sciences, Engineering, or related field; Master’s degree preferred
- • Minimum of 5 years of experience in quality engineering or post-market surveillance within the medical device or IVD industry
- • Proven experience with FDA 21 CFR Part 803, EU MDR Article 87, and ISO 13485 requirements for complaint handling and adverse event reporting
- • Hands-on experience with electronic QMS platforms (e.g., Veeva, MasterControl, or similar)
- • Strong understanding of root cause analysis methodologies (e.g., 5 Whys, Fishbone, FMEA)
- • Experience preparing and submitting Medical Device Reports (MDRs) and Field Safety Corrective Actions (FSCAs)
🏖️ Benefits
- • Comprehensive health, dental, and vision insurance
- • Paid time off and company holidays
- • 401(k) plan with company match
- • Professional development and training opportunities
- • Onsite wellness programs and employee resource groups
- • Generous parental leave policy
Skills & Technologies
Senior
Onsite
About GRAIL, Inc.
GRAIL develops multi-cancer early-detection blood tests using high-intensity sequencing, population-scale clinical trials, and machine learning. Its Galleri test screens for over 50 cancers from a single blood draw, aiming to shift diagnosis from late-stage symptoms to early, treatable stages. The company conducts large prospective studies, partners with health systems, and pursues FDA approval to integrate screening into routine care. Founded in 2016 as a spin-out from Illumina, GRAIL operates laboratories in the United States and the United Kingdom and focuses on evidence generation, regulatory science, and equitable test access.
Get more remote jobs like this
Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.
Newsletter
Weekly remote jobs and featured talent.
No spam. Only curated remote roles and product updates. You can unsubscribe anytime.
Similar Opportunities
Expired
Patch My PC, LLC
United States
Full-time
Expired May 3, 2026
Azure
Kubernetes
DevOps
+1 more
3 months ago