EMC/EMI System Engineer leading analysis, testing, and validation for satellite systems at Fastwater Staffing. Collaborating with cross - functional teams to ensure compliance with industry standards.
About the role
- Quality Management System Engineer overseeing quality management for Flow Cytometry software at Dotmatics. Transforming OMIQ SaaS into a validation-ready solution aligned with GxP standards.
Responsibilities
- 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
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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Report this job
Found something wrong with the page? Please let us know by submitting a report below.
LP
Senior Systems Engineer (Systems Delivery)
LinkedIn Recruiter Post
Xanadu is building quantum computers. As a Senior Systems Engineer, you will develop test plans, define best practices, and coach the team.
Project Manager & Systems Engineer in Energy Storage Solutions overseeing energy storage, micro grid management, and power distribution projects. Technical expert managing projects from presales to commissioning activities including compliance with North America regulations.
Sr. Revenue Systems Analyst optimizing sales operations and driving data - driven insights at Powerfleet. Collaborating with global teams to improve revenue efficiency and operational workflows.
Payload System Verification & Validation Engineer supporting verification and validation of digital telecommunications payloads. Developing test plans and ensuring the performance of payload architectures.
Satellite Platform RF/EMC Systems Engineer supporting RF and EMC systems for advanced satellite platforms. Involves design, integration, testing, and collaboration across multidisciplinary teams.
Satellite Platform TT&C Systems Engineer designing and validating RF communication systems for advanced satellite platforms with multidisciplinary engineering teams across different domains.
Director of CX Systems Architecture at Wealthsimple overseeing technology solutions for exceptional customer experiences. Focused on AI integration and systems architecture in financial services.
Intermediate Mechanical Designer at Carmeuse responsible for designing packaged equipment and systems. Involves preparing detailed drawings and ensuring compliance with industry standards in Milton, ON.
Building Systems Engineer working with data and engineering teams to enhance commercial building efficiency. Focused on customer value and product development in a tech - driven environment.