Staff Digital Quality Systems Engineer (temporary position)
Core
Operational extension of Global eDHR Product Owner and Windchill PLM Quality Business Process Owner driving development, deployment, governance, and continuous improvement of enterprise Digital Quality Systems.
Role type
Staff Digital Quality Systems Engineer (temporary contract)
Builds
Enterprise Digital Quality Systems (eDHR and PLM) supporting manufacturing operations and product lifecycle management
Domain
Medical device manufacturing / Quality Systems / Digital Transformation
Required skills
Quality Systems Management, Digital Transformation, Change Management, Business Process Ownership, Data Integrity, Continuous Improvement, Stakeholder Management, Regulatory Compliance (FDA 21 CFR Part 820/11, ISO 13485), GxP requirements development, Validation Lifecycle, Project Management, Root Cause Analysis
Preferred skills
eDHR, PLM, Windchill, Tulip, Agile/Scrum, Jira, Change Control, Document Control (via careerplan.io/jobs/R92303-staff-digital-quality-systems-engineer-temporary-position-at-smithnephew)
Technologies
eDHR, PLM, Windchill, Tulip, Jira
Responsibilities
Coordinate system enhancements, releases, issue resolution, and stakeholder alignment; Interpret disparate business processes and drive standardization across business units; Lead deployment, training, communication, and adoption activities globally; Support enterprise eDHR and PLM strategy, governance, and roadmap execution; Lead process creation for change control and lifecycle management; Ensure data integrity, compliance, audit readiness, and regulatory alignment; Define business requirements and assess impact to prioritize features and initiatives.
Seniority
Staff (P4 level), hands-on IC with strategic influence
