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Posted: 10/19/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Systems and computerized system validation, with a strong focus on regulatory compliance and risk-based validation strategies. Proficient in translating business and Quality requirements into effective digital workflows and system functionalities.
Highest-signal resume keywords
Quality Systems ExpertiseComputerized System ValidationRegulatory Compliance KnowledgeRisk-Based Validation StrategiesData Analysis and Reporting
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Own CSV/CSA activities for eQMS platforms, ERP Quality functionality, and other computerized applications supporting Quality processes
- Develop risk-based validation strategies and maintain validation documentation
- Coordinate and execute testing for new systems, configurations, integrations, enhancements, upgrades, and significant changes
- Maintain systems in a validated state throughout their lifecycle
- Support investigation and resolution of validation deviations and system-related quality issues
- Serve as a Quality functional SME and super-user for eQMS, ERP Quality modules, and other Quality applications
- Translate business and regulatory requirements into digital workflows and system requirements
- Support configuration, implementation, testing, deployment, and enhancement of Quality system functionality
- Simplify, standardize, and automate Quality processes
- Convert manual, paper-based, or spreadsheet-driven processes into controlled electronic workflows
- Develop process maps, functional requirements, user requirements, and workflow designs
- Support integrations between Quality applications and ERP, document management, training, manufacturing, supplier, and other business systems
- Partner with IT and software vendors to troubleshoot issues and coordinate enhancements
- Support user acceptance testing, deployment, training, and adoption of digital Quality processes
- Develop and maintain Quality metrics, dashboards, and reporting tools
- Analyze Quality data to identify trends, risks, recurring issues, and improvement opportunities
- Support reporting and trending for CAPA, nonconformance, complaints, audits, suppliers, inspection, and training
- Establish KPIs and measures of process effectiveness with process owners
- Automate recurring Quality reports and support Quality Management Review and leadership reporting
- Maintain computerized Quality system inventories, lifecycle information, periodic reviews, and change impact assessments
- Support user access reviews, vendor assessments, data migration, upgrades, retirement, archival, and record retention
- Support remediation of system-related audit findings, data integrity concerns, and compliance gaps
- Support compliance with 21 CFR Part 11, FDA QMSR, ISO 13485, electronic records, electronic signatures, and computerized system requirements
- Support internal audits, customer audits, and regulatory inspections involving Quality computerized systems
Requirements
What you’ll need- Bachelor’s degree in Engineering, Computer Science, Information Systems, Quality, Life Sciences, Data Analytics, or a related technical discipline
- 3+ years of experience in Quality Systems, Quality Engineering, computerized system validation, digital Quality, business systems, or a related function within a regulated industry
- Working knowledge of 21 CFR Part 11, FDA QMSR, and ISO 13485
- Familiarity with Computer Software Assurance (CSA), CSV, GAMP 5, and risk-based validation principles
- Experience supporting computerized systems within a Quality or regulated environment
- Experience with system requirements, testing, validation, change control, or system implementation
- Working knowledge of Quality Management Systems and regulated business processes
- Strong analytical skills with experience analyzing and presenting Quality or operational data
- Ability to translate business and Quality requirements into system requirements and practical solutions
- Strong technical writing, documentation, problem-solving, and organizational skills
- Ability to work effectively across Quality, IT, Operations, business functions, and external vendors
- Candidates must be based remotely in the US, with a strong preference for Eastern and Central Time Zones
- Preferred: Medical device industry experience
- Preferred: Experience with eQMS and/or ERP Quality functionality
- Preferred: Experience with CAPA, nonconformance, document control, training, audit, supplier quality, complaint, or change management applications
- Preferred: Experience developing Quality dashboards, metrics, automated reporting, or data visualization
- Preferred: Experience with cloud/SaaS applications and vendor-managed systems
- Preferred: Familiarity with data integrity, electronic records, electronic signatures, audit trails, and computerized system lifecycle management
- Preferred: Experience supporting regulatory inspections or customer audits involving computerized systems
Benefits
Comp & perks- Medical insurance
- Prescription drug insurance
- Dental insurance
- Vision insurance
- Flexible spending accounts
- Participation in 401(k) savings plan
- Paid time off (PTO)
- Short- and long-term disability
- Parental leave
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Management SystemsSystem Requirements DevelopmentValidation DocumentationTesting and ImplementationChange ControlQuality Metrics DevelopmentAutomated ReportingProcess MappingDigital Quality WorkflowsCAPA Management
Soft Skills
Analytical SkillsTechnical WritingProblem-SolvingOrganizational SkillsCollaboration
Tools & Technologies
EQMSERP Quality FunctionalityCloud/SaaS ApplicationsData Visualization ToolsDocument Management Systems
Industry Keywords
21 CFR Part 11FDA QMSRISO 13485Computer Software AssuranceGAMP 5Regulated Industry ExperienceMedical Device IndustryData IntegrityElectronic RecordsAudit Trails