QA Validation & Qualification Engineer

QA VALIDATION & QUALIFICATION ENGINEER – TEMPORARY UNTIL END 2026

AliveDx is recruiting for a QA Validation & Qualification Engineer to join our Quality team – a key function responsible for ensuring product quality, compliance, and timely release of materials and finished products. The role is a full-time temporary position until end of 2026 based in Eysins, Switzerland.

YOUR MISSION

As a QA Validation & Qualification Engineer, you will be responsible for supporting manufacturing quality activities related to raw materials, intermediates, and finished products, ensuring compliance with operational objectives, regulatory requirements, and current Good Manufacturing Practices (cGMP).

You will :

• Perform Quality Assurance release of incoming goods, intermediate, and final products in accordance with established procedures


• Ensure accurate recording and compliant completion of all quality and operational documentation


• Maintain quality documentation and computerized systems including batch records, specifications, SOPs, ERP, and QMS records


• Monitor and report quality metrics related to non-conforming materials and incoming inspections


• Support qualification activities for new and existing equipment and systems


• Contribute to Quality Management System activities including non-conformance assessment, change control, and quality meetings


• Support internal and external audits from customers and regulatory authorities


• Participate in deviation investigations, root cause analysis, and continuous improvement initiatives


• Ensure compliance with GMP, regulatory, and Health & Safety requirements in all activities


• Collaborate cross-functionally and contribute to operational excellence within the Quality department

This role requires strong attention to detail, a quality-driven mindset, and the ability to work collaboratively across functions in a regulated environment to ensure product safety, compliance, and business continuity.

YOUR COMPETENCIES

• Bachelor’s degree in quality management or in Sciences (Pharmaceutical/Biotechnologies)


• Minimum of 5 years of experience within a regulated industry


• Good knowledge and working experience and expertise of ISO 13485, 98/97/EC IVD Directives and FDA Code of Federal Regulations.


• Proactive, communicative and solution-oriented personality


• Self-confident with the ability to work with all levels of the organisation.


• Fluent in English, French is an asset.

WHAT WE OFFER

• A highly dynamic and growing environment,


• An opportunity to live your passion for an intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do,


• A flexible working environment where applicable and a range of core and flexible benefits, ranging from lunch allowance support, additional annual leave, cycle to work scheme, technology and access to marketplace discounts.