Quality System Specialist
Vor 4 Tagen
AliveDx is seeking a Quality System Engineer to join our Quality Assurance team based in Switzerland.
This is a 12-month full-time position.
The Quality System Engineer will lead the implementation and transition of our Quality Management System from a manual or legacy system to an electronic Quality Management System (eQMS) in compliance with ISO 13485 standards.
The successful candidate will also lead the integration of Medical Device Single Audit Program (MDSAP) requirements into our existing Quality Management System (QMS).
Key Responsibilities:
- Lead the end-to-end transition to an electronic Quality Management System (eQMS) ensuring alignment with ISO 13485 requirements.
- Cross-Functional Collaboration: Work closely with IT, Quality Assurance, Regulatory Affairs, and other departments to ensure seamless integration of the eQMS with existing processes and systems.
- ISO 13485 and Regulatory Compliance: Ensure the eQMS meets ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulatory standards.
- Training and Change Management: Develop and implement a comprehensive training program for end users ensuring staff are proficient in the use of the new eQMS and drive change management.
- Vendor Management: Manage relationships with eQMS vendors ensuring timely delivery of system components and services.
- Risk and Issue Management: Identify potential project risks, develop mitigation strategies, and implement contingency plans to address unforeseen challenges.
For MDSAP implementation, the Quality System Engineer will lead the implementation of MDSAP requirements within the organization ensuring full compliance with participating countries' regulations and alignment with ISO 13485.
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