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QA Validation & Qualification Engineer

AliveDx -
Eysins, VD

Jetzt bewerben

Details zur Stelle

Temporär | 100%
vor 8 Tagen

Qualifikationen

Französisch
Englisch
Bachelor
ISO 13485

Vollständige Stellenbeschreibung

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.

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.

Interested? We invite you to send your application, including your resume and any other relevant documents. We look forward to exploring your potential contributions to AliveDx.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, religion/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.

Jetzt bewerben

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QA Validation & Qualification Engineer

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