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Quality Management System Engineer – QMS

Systems EngineerSystems EngineerFull TimeRemoteLeadTeam 501-1,000H1B SponsorCompany SiteLinkedIn

Location

Canada

Posted

68 days ago

Salary

0

Seniority

Lead

Bachelor Degree7 yrs expEnglish

Job Description

Quality Management System Engineer – QMS

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 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 • Develop, author, maintain, and train on 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 • Act as the primary scout for the division on shifting regulatory landscapes

Job Requirements

  • 7+ years in the Biopharma/MedTech space
  • 5 years 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 and lead a strategic product roadmap session
  • Exceptional ability to explain complex technical architectures to non-technical Quality Officers

Benefits

  • Competitive salary
  • Remote work options
  • Professional development opportunities

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