Senior Quality Engineer
Core
Manage product change requests and standards to ensure compliance with medical device quality management systems and regulatory requirements.
Role type
Senior Quality Engineer (Change Management & Standards)
Builds
Compliant medical device product changes and updated quality standards
Domain
Medical Devices / Quality Management Systems
Required skills
Change management, Root cause analysis, 7 QC tools, CAPA, ISO 13485, FDA 21CFR Part 820, Windchill onePLM, TrackWise, Standards management, Power Platform tools
Responsibilities
Process Enterprise Change Requests (ECRs) and Enterprise Change Notices (ECNs) in Windchill onePLM, Facilitate change implementation board meetings and cross-functional impact assessments, Own and maintain the standards management process, Coordinate stakeholder reviews and approvals for standards updates, Review and update procedures, Utilize power platform tools to automate processes