Quality System Engineer

at  AliveDx

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

QUALITY SYSTEM ENGINEER (12 MONTHS)

AliveDx is seeking a Quality System Engineer to join our Quality Assurance department based in Eysins, Switzerland. This is a full-time and temporary position for 12 months.

1) KEY RESPONSIBILITIES FOR EQMS TRANSITION:

Lead the end-to-end transition to an electronic Quality Management System (eQMS), ensuring alignment with ISO 13485 requirements.

2) KEY RESPONSIBILITIES FOR MDSAP IMPLEMENTATION:

• Lead the implementation of MDSAP requirements within the organization, ensuring full compliance with participating countries’ regulations and alignment with ISO 13485.
• Develop and manage a detailed project plan outlining key milestones, timelines, resources, and deliverables for the MDSAP implementation process.
• Interpret MDSAP requirements and ensure they are integrated into the company’s QMS in compliance with ISO 13485 and local regulatory requirements (e.g., FDA, Health Canada, ANVISA, TGA, PMDA).
• Oversee the creation or revision of Standard Operating Procedures (SOPs), work instructions, and other documentation to ensure compliance with MDSAP audit criteria.
• Work closely with departments such as Quality Assurance, Regulatory Affairs, Manufacturing, and Supply Chain to ensure MDSAP requirements are effectively implemented across all functions.
• Collaborate with external consultants or regulatory experts to support the MDSAP implementation and address complex regulatory requirements.