Quality Management System Engineer | OMIQ

Dotmatics is a leading provider of a comprehensive digital science platform, supporting scientific innovation across the globe. The Quality Management System Engineer will oversee and drive quality management processes for Flow Cytometry software, ensuring compliance and validation in biopharma environments.

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

Requirements:

• 7+ years in the Biopharma/MedTech space
• At least 5 years specifically focused on Computer System Validation (CSV) and Quality Management for SaaS
• 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
• Ability 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