About 3Brain AG

We are a pioneering Swiss deep tech company working on cell-electronic interfaces that link biological networks to computers via custom-made semiconductor microchips. Our mission is to empower life scientists to probe intelligent networks, accelerate biomedical discoveries for the benefit of patients, and create a future more exciting than the present. We are ambitious, fast-growing and love to explore.

We are the world’s first company to connect cells with sophisticated silicon chips in cell culture plates and our cutting-edge products are used in laboratories and pharma companies all over the world. At 3Brain, we offer a stimulating and highly collaborative work environment driven by a desire to build transformational technologies to help others.

Join us, and together, we'll engineer a brighter future!

About the role

We are looking for a talented and experienced Production and Quality Assurance (QA) Manager with a strong background in electronics to join our executive team. She/He will be responsible for overseeing our company's production and qa team, with a primary focus on manufacturing of electronic devices for life science applications. Furthermore, you will also ensure that the company’s products and processes comply with the latest international quality standards.

The ideal candidate will have a proven track record in scaling production, implementing QA processes and ensuring regulatory compliance within a fast-paced and regulated environment. Main responsibilities:

Production:

• Oversee the production process, ensuring efficient and timely manufacturing of electronic devices for life science applications.
• Optimize production workflows, resource allocation, and capacity planning to meet production targets.
• Supervise and train production staff to ensure adherence to processes and standards.
• Maintain and organize all production-related documentation, including workflows, processes, and operational records, ensuring accessibility and adherence to documentation control standards.

Quality Assurance:

• Develop and enforce quality assurance policies and procedures aligned with regulatory standards.
• Implement and manage robust tracking systems for all components and parts, including serial or batch tracking, to ensure traceability for complex mechanical and electronic instruments.
• Investigate non-conformances, conduct root cause analyses, and implement corrective actions together with the QA team.
• Oversee the validation of new products upon development completion and the release of finished products after thorough quality review and approval.
• Ensure compliance with relevant regulatory standards, norms and guidelines, such as CE, ISO, FDA, and other regulations.

You should have:

• Bachelor’s degree in electronics or mechanical engineering or technical diploma with significant relevant experience.
• Strong background and understanding of electronics manufacturing and processes, quality test of electronics, production environments, production optimization and product maintenance.
• Experience in manufacturing and inventory management systems that support traceability and compliance in complex product assemblies.
• Excellent leadership and people management skills, with the ability to motivate and inspire teams.
• Strong problem-solving and decision-making abilities, with a strategic mindset.
• Outstanding communication, presentation, and interpersonal skills.

Additional Qualifications

• Hands-on experience and in-depth knowledge of regulatory compliance standards (e.g., CE marking, ISO certifications, FDA regulations) is a strong plus.
• Previous experience in life science companies, especially those active in sectors like Medical Devices, Diagnostics, Bioinformatics, Bioengineering and Life Science Research and Development would be an advantage.
• Knowledge of microtechnology, silicon microchip technology, and Microelectromechanical Systems (MEMS).

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