Founded in 2005, Dotmatics is self-described as the world’s largest research and development scientific software platform, used by leading researchers in biopharma, academia, and
Quality Management System Engineer
Location
United States
Posted
43 days ago
Salary
$91.0K - $123.2K / year
Seniority
Lead
Job Description
Quality Management System Engineer
Dotmatics
• Oversee and drive quality management framework and processes for Flow Cytometry software • Transform OMIQ SaaS platform into a fully validation-ready solution • Architect QMS in alignment with Dotmatics GxP policies and procedures • Lead all validation efforts and serve as the technical face of Quality for biopharma customers • Design, implement, and maintain a functional QMS for the Flow Cytometry division • Engage in the development and maintenance of critical validation documentation • Define the roadmap for compliance-specific features • Serve as the technical subject matter expert during the sales cycle • Partner with Engineering to integrate automated testing and validation checkpoints • Scout for shifting regulatory landscapes
Job 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
- Deep understanding of Flow Cytometry data analysis workflows
- 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
- Exceptional ability to explain complex technical architectures to non-technical Quality Officers
- Ability to “right-size” Quality systems and validation efforts based on risk.
Benefits
- Medical, Dental, Vision, Insurance
- Health Spending Accounts
- Wellness Benefits (Mental Health Apps and Fitness Perks)
- Company-paid Life and Disability Insurance
- 401k Retirement Plan (with 4% company match; immediate vesting)
- Flexible Time off Plan (for US exempt employees)
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