Quality Management System Engineer (QMS) | OMIQ

Our Why At Dotmatics

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.

What do we need

As the Quality Management System (QMS) owner you will oversee and drive quality management framework and processes that support the delivery of our Flow Cytometry software into regulated biopharma customer environments (typically clinical development and QC labs). In addition to supporting our existing FCS Express clinical and validation-ready software that is already extensively used in regulated labs, this role is especially targeted at transforming our OMIQ SaaS platform into a fully validation-ready solution that meets the requirements of customers wishing to deploy OMIQ into GxP-compliant environments, ensuring our customers can transition from research to clinical trials with absolute confidence in our data integrity and quality standards.

This is a role where the successful candidate will architect our QMS in alignment with Dotmatics GxP policies and procedures as well as industry standard guidance including but not limited to ISO 9001, 13485 (21 CFR part 820), ICH Q10, and PIC/S. Additionally, the person in this role will lead all validation efforts, and serve as the technical face of Quality for biopharma customers using our Flow Cytometry products in alignment with 21 CFR part 11, GAMP 5, 21 CFR part 58, and other relevant regulatory frameworks.

In this role you will get to

• Quality Management Leadership: Design, implement, and maintain a functional QMS for the Flow Cytometry division that aligns with corporate standards while remaining optimized for SaaS delivery.
• Validation Asset Creation: 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.
• Product Strategy: 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.
• Customer Advocacy & Sales Support: 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.
• Process Integration: Partner with Engineering to integrate automated testing and validation checkpoints into their existing SDLCs, moving toward a model of "Continuous Validation."
• Regulatory Intelligence: Act as the primary scout for the division on shifting regulatory landscapes for clinical software.
• Enterprise Alignment and Partnership: 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.

We are looking for people who have

• 7+ years in the Biopharma/MedTech space, with at least 5 years specifically focused on Computer System Validation (CSV) and Quality Management for SaaS, and hold a B.S. or Advanced Degree in Life Sciences (Immunology/Hematology preferred) or Computer Science.

The key skills we are looking for

• Computer System Validation (CSV) and Quality Management for SaaS.
• Technical Domain Knowledge: Deep understanding of Flow Cytometry data analysis workflows and the unique challenges of high-dimensional biological data.
• Regulatory Mastery: Proven track record of navigating 21 CFR Part 11, GAMP 5, ISO 9001 and/or ISO 13485, and HIPAA/GDPR requirements.
• A Hybrid Skillset: Ability to write a technical risk assessment in the morning and lead a strategic product roadmap session in the afternoon.
• Communication: 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.
• Risk Management: 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.

Research shows us the confidence gap and imposter syndrome can get in the way of meeting outstanding candidates, so please don’t hesitate to apply — we’d love to hear from you.

By submitting your application, you agree that Dotmatics may collect your personal data for recruiting, global organization planning, and related purposes. Dotmatics Privacy Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over Dotmatics use of your personal information.

Dotmatics is an equal opportunity employer. We are a welcoming place for everyone, and we do our best to make sure all people feel supported and connected at work.

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