Quality Manager

Location: Munich / Germany

Type: Full-time

About us

Amplifold is pioneering the next generation of molecular diagnostics through breakthrough molecular design and DNA nanotechnology. By reimagining how biomolecules are assembled and interact, we are unlocking new levels of precision, speed, and sensitivity in immunoassays and related diagnostic platforms.

We are a small, ambitious team of scientists and entrepreneurs with a shared drive to push the boundaries of diagnostic performance. At Amplifold, everyone contributes to shaping our technology, our culture, and our impact - combining scientific rigor with an entrepreneurial spirit.

Our goal is to bring our innovative lateral flow diagnostic tests to market in Europe under ISO 13485 and IVDR. To support this mission, we are seeking a Quality Manager who will work closely with R&D, Regulatory, and Operations to build and maintain an efficient, compliant, and lean quality management system.

If you are motivated by hands-on quality work, close collaboration with scientists and engineers, and helping innovative diagnostic products reach the market, Amplifold offers an exciting opportunity to make a tangible impact.

Your Responsibilities

• Take a key role in the establishment, implementation, and maintenance of Amplifold's Quality Management System according to ISO 13485.
• Collaborate closely with R&D to integrate quality requirements early in product design, verification, and validation.
• Maintain and improve documentation systems, including SOPs, work instructions, templates, and records.
• Support Design Control processes and contribute to the creation of Design History Files (DHF) and Device Master Records (DMR).
• Conduct or coordinate internal audits, CAPA processes, and supplier evaluations.
• Prepare and support external audits (Notified Body, certification, customer, or supplier audits).
• Monitor compliance with IVDR and FDA requirements in collaboration with Regulatory Affairs.
• Provide training and guidance to project teams on quality processes and good documentation practices.
• Contribute to continuous improvement of quality and operational processes to ensure both compliance and efficiency.
• Act as Safety Officer or support laboratory safety management (qualification or willingness to train is a plus).

Your Profile

• Degree in life sciences, medical technology, biotechnology, or a related field.
• 2–5 years of professional experience in Quality Management for in vitro diagnostics or medical devices.
• Solid understanding of ISO 13485 and related standards (ISO 14971, IEC
• Experience supporting R&D teams in design control, verification/validation, and documentation.
• Hands-on laboratory experience (e.g., assay development, testing, or molecular biology techniques).
• Familiarity with European IVDR or FDA QSR is a plus.
• Qualification or interest in acting as Safety Officer (Gefahrstoffbeauftragter / Sicherheitsbeauftragter) is a plus.
• Practical, solution-oriented mindset with a passion for efficient, lean processes in a start-up environment.
• Strong organizational skills, attention to detail, and clear written communication.
• Collaborative team player who enjoys working across scientific and operational disciplines.
• Fluent in English; German is a plus.

We Offer

• The opportunity to build and shape a high-quality foundation for next-generation diagnostics.
• A small, dynamic team where quality, science, and innovation go hand-in-hand.
• Direct collaboration with experienced regulatory and scientific leaders.
• Room to design efficient processes, take ownership, and grow with the company.
• A meaningful role in bringing novel diagnostic technologies to patients and clinicians worldwide.
• This position is based in Munich, Germany.

Please submit your application to before December 14th 2025.