Quality Systems Specialist
Vor 4 Tagen
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.
About The RoleWe are seeking a talented and experienced Production and Quality Assurance (QA) Manager with a strong background in electronics to join our executive team. As a key member of our team, you will oversee our production and QA process, ensuring efficient and timely manufacturing of electronic devices for life science applications.
- 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.
- 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.
- 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.
- Hands-on experience and in-depth knowledge of regulatory compliance standards (e.g., CE marking, ISO certifications, FDA regulations).
- 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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