Senior Staff Specialist, Change Management
Core
Lead high-complexity projects to evolve quality management systems and business performance, acting as a change analyst and approver for process and procedure changes.
Role type
Senior Staff Specialist, Change Management (Quality Management System)
Builds
Quality Management Systems (QMS) and change control processes
Domain
Medical Device Industry / Quality Assurance
Required skills
Change control process expertise, Regulatory compliance (ISO 13485, MDSAP, CFR Part 820), Audit preparation and coordination, KPI management and reporting, Training development and delivery, Continuous improvement initiatives, Cross-functional collaboration
Preferred skills
Subject matter expertise in change control, Experience with OnePLM and Agile systems, Mentorship of change owners
Technologies
OnePLM, Agile
Responsibilities
Review and approve changes to processes and procedures for compliance; Lead change control review forums; Manage site change control KPIs and reporting; Coordinate audit preparation for internal and third-party compliance; Develop and deliver training on change control processes; Drive continuous improvement opportunities for QMS efficiency.
Seniority
Senior Staff, hands-on IC with leadership responsibilities