Quality Systems Specialist
Distalmotion SA
·Yesterday
- Location
- Épalinges, Vaud, Switzerland
- Workplace
- Onsite
- Type
- Full-time
- Department
- Quality Assurance
- Experience
- 5+ years
- Source
- Workable
Description
The Quality Systems Specialist is responsible for the development, structure, maintenance, and improvements of the Quality Management System.
Tasks:
Tasks:
· Lead identification, development, architecture, and optimizations of the Quality Management System, at both Global and Site levels.
· Work collaboratively and support process owners in reviewing, structuring, and documenting their functional new or improved processes. Structure and integrate multi-referential in the same management system such as IT management system Business Continuity Management system, EHS, finance.
· Author procedures, policies, work instructions, and related documents with style, content, and format guidelines in compliance with ISO 13485, 21CFR820, EU MDR, MDSAP and other applicable regulations.
· Actively monitor effectiveness of the quality management system and propose and execute improvement projects.
· Lead complex quality initiatives (e.g. CAPA, process improvements, new processes, gap analyses, system integrations), make recommendations, develop and execute plans.
· Plan and conduct internal audits by participating and leading internal audits, follow up on the findings with auditee through effective closure, and present the data for trending.
· Support electronic QMS transition and take ownership of the software tools including QMS documentation and change control.
· Support Operational Quality with the handling of non-conformities, tool activities approvals, finish product release.