Quality Management System Engineer | OMIQ

Dotmatics

33d • Remote

About The Position

At Dotmatics, we believe science, data, and decision-making must be deeply intertwined for innovation to thrive. Our Portfolio includes Luma, LumaLab Connect, ELN Platform, Graphpad Prism, Geneious, SnapGene, Protein Metrics, OMIQ, FCS Express, LabArchives, NQuery, EasyPanel, MStar, SoftGenetics and Virscidian. We have a vision for a new Lab of the Future that will change the future of scientific research. We have created the world’s most comprehensive digital science platform – best-of-breed software applications already used by more than 2 million scientists, together in a single ecosystem united by a powerful, flexible enterprise data platform. This is not flat data buried away in digital graveyards. This is dynamic, multi-dimensional decision-making. Scientific enterprises need a new level of effectiveness to achieve tomorrow’s breakthroughs. Illness will not wait. The biosphere will not wait. We are tireless in our vision, because the time for innovation is now. Shaping the Future of Science At Dotmatics Our global team of more than 800 colleagues are dedicated to supporting our customers in over 180 countries. Together, with our scientific community of users, we accelerate scientific innovation in order to make the world a healthier, cleaner, and safer place to live. You’ll join a collaborative, global team pushing the boundaries of scientific innovation. Your ideas and efforts will have a tangible impact, accelerating scientific progress and discovery. We offer a dynamic, remote-friendly environment that fosters high integrity and collaboration, empowering you to excel. Dotmatics is a company built by scientists, for scientists. Combined, we are now the world’s largest cloud-based scientific research R&D platform. We need your help to keep growing and pioneering the future. We are Science Driven. We are Customer Centric. We are Better Together.

Requirements

• 7+ years in the Biopharma/MedTech space, with at least 5 years specifically focused on Computer System Validation (CSV) and Quality Management for SaaS.
• Hold a B.S. or Advanced Degree in Life Sciences (Immunology/Hematology preferred) or Computer Science.
• Computer System Validation (CSV) and Quality Management for SaaS.
• Deep understanding of Flow Cytometry data analysis workflows and the unique challenges of high-dimensional biological data.
• Proven track record of navigating 21 CFR Part 11, GAMP 5, ISO 9001 and/or ISO 13485, and HIPAA/GDPR requirements.
• Ability to write a technical risk assessment in the morning and lead a strategic product roadmap session in the afternoon.
• Exceptional ability to explain complex technical architectures to non-technical Quality Officers and vice-versa. Able to teach and train staff on Validation, GxPs, and processes.
• Ability to “right-size” Quality systems and validation efforts based on the overall risk of the product as related to patient safety, product quality, data integrity, confidentiality, and availability.

Responsibilities

• Design, implement, and maintain a functional QMS for the Flow Cytometry division that aligns with corporate standards while remaining optimized for SaaS delivery.
• Deeply engage in the development, authoring, maintaining and training of critical validation documentation, including User Requirements Specifications (URS), Risk Assessments (FMEA), Configuration Specifications, IQ/OQ/PQ and Validation Summary Reports.
• Define the roadmap for compliance-specific features, ensuring that audit trails, e-signatures, and data residency requirements evolve alongside clinical regulatory trends (21 CFR Part 11, Annex 11, ALCOA+) and enterprise requirements.
• Serve as the technical subject matter expert during the sales cycle, leading "Quality Deep Dives" with customer Quality Assurance (QA) and IT departments to facilitate successful audits and system adoption.
• Partner with Engineering to integrate automated testing and validation checkpoints into their existing SDLCs, moving toward a model of "Continuous Validation."
• Act as the primary scout for the division on shifting regulatory landscapes for clinical software.
• Partner with the Dotmatics Security and Trust team to align QMS, ISMS and GxP programs, continually develop programs and provide input and suggestions into future states.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior