Quality Systems Specialist
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.
Requirements
Required abilities:*
- Degree in Engineering, Scientific
- 5+ years of quality-related system experience in a medical device company developing medical devices
- Excellent technical writing, proofing, and language (grammar and spelling) skills with strict attention to details
- Significant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR)
- Certified lead auditor for ISO 13485
- Knowledge in certification 27001 is a plus
- Excellent communication skills and interpersonal relationship skills
- Advanced problem-solving, organizational, analytical and critical thinking skills
- Electronic QMS experience is preferred
- Fluency in English is a must
Benefits
What we offer:*
- A dynamic, innovative environment with cutting-edge medical technology that is shaping the future of robotic surgery.
- Fast-growing Company where innovation meets agility.
- Structured onboarding program and training, ensuring a confident start.
- High degree of autonomy and flexibility.