Quality Manager - Instruments and Software (Remote)

About the Role

We are seeking a dedicated Quality Manager - Instruments and Software to join our team remotely. In this versatile role, you will oversee our devices developed and manufactured according to ISO 13485, focusing on application, control, device, and standalone software throughout the entire product lifecycle. As a Quality Manager, you will ensure that our devices and software solutions are reliable, error-free, and maintainable.

What You'll Do

• Guide software project teams and development, QC, and production areas proactively to achieve qualitative and quantitative goals.
• Review batch documentation and independently release manufactured devices for sale.
• Coordinate deviations, CAPAs, and change requests effectively.
• Contribute to risk analyses and qualification and validation documentation.
• Actively participate in quality meetings to promote clear interdisciplinary communication.

Requirements

• A degree in a STEM field, such as engineering (biotechnology, mechanical engineering, electrical engineering, medical technology) or equivalent education.
• Practical experience in hardware or software development within a quality management system according to ISO 13485 or ISO 9001.
• Knowledge of relevant standards and regulations such as ISO 13485, IEC 62304, ISO 14971, and FDA QSR (21 CFR 820) is highly advantageous.
• Strong analytical and structured thinking skills with excellent document review capabilities.
• Fluent in both German and English, both written and spoken.

Nice to Have

• Experience in verification and validation activities for hardware and/or software.
• Strong interpersonal skills with the ability to work effectively in a team.
• Experience in a multicultural environment.

What We Offer

• Flexible working hours and the ability to work independently.
• An intercultural environment characterized by diversity and flat hierarchies.
• Opportunities for individual training through our Miltenyi University.
• 30 days of vacation, discounted Germany ticket, and asset-building benefits.
• A supportive team environment that values creativity and diverse perspectives.