Quality Specialist

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Secure cell is a Swiss technology company at the intersection of biotechnology, engineering, and healthcare. For more than three decades, we have been developing innovative solutions that help advance scientific discoveries and improve people's lives. Combining deep expertise in bioprocess control with a strong culture of innovation, we collaborate across disciplines to transform complex challenges into practical technologies that create real-world impact.

Continuing steadily on our sustainable innovation path and growth journey, we are looking for a

for our Quality Assurance & Regulatory Affairs team

This is more than just a job. It is an opportunity to contribute to technologies that support groundbreaking scientific discoveries and help shape the future of biotechnology and healthcare.

As a Quality Specialist, you will play a key role in ensuring the quality, compliance, traceability, and accessibility of documentation and quality records supporting innovative biotechnology and medical technology products throughout their lifecycle. Working closely with colleagues across Engineering, Operations, and Project Management, you will help maintain the highest quality standards while supporting the successful delivery of products and solutions to customers worldwide.

Whether you are improving existing technologies, driving innovation, or solving complex technical challenges, your contributions will have a direct impact on our success and future growth.

You will be part of our Quality Assurance & Regulatory Affairs team and be responsible for the creation, maintenance, control, and continuous improvement of quality and project documentation. In this role, you will oversee document control activities, support quality inspections and, coordinate quality records, and contribute to the ongoing development and effectiveness of our Quality Management System.

• Organize, coordinate, and manage project-related documentation throughout its lifecycle, including review, release, publication, and archiving
• Perform Incoming Quality Inspections, in-process controls, and Factory Acceptance Tests (FAT) according to approved procedures and specifications
• Create, review, and maintain Quality Management System (QMS) documentation and project-specific quality records
• Gather, compile, and consolidate technical information by collaborating with cross-functional teams, suppliers, subject matter experts, and external partners
• Support the preparation and maintenance of technical documentation, including work instructions, operating manuals, test plans, reports, and technical files
• Ensure project and quality documentation is accurate, compliant, and readily retrievable in both electronic and paper formats
• Contribute to the continuous improvement of documentation processes, tools, and quality-related practices
• Proactively communicate potential issues, deviations, and documentation gaps to project leaders and line management
• Provide administrative and documentation support to project and quality teams as required
• Collaborate closely with Production, Project Management, Systems Engineering, and other stakeholders to ensure quality and compliance objectives are achieved
• Support quality assurance activities and continuous improvement initiatives across the organization

You enjoy solving complex technical challenges and thrive in an environment where electronics, embedded software, sensing technologies, and medical innovation come together. You are proactive, hands‑on, and motivated to develop…