Quality Management Engineer (f/m/x) 2-Year Fixed-Term Contract

zeissgroup; Berlin; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

ZEISS Medical Technology in Berlin seeks a Quality Management Engineer to ensure safety, effectiveness, and regulatory compliance of medical devices across their lifecycle.

You will work with R&D, Engineering, Regulatory Affairs, and manufacturing to optimize product quality, perform risk assessments, audits, and drive QMS improvements in a fast-paced environment.

Qualifikationen

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences or related discipline.
• Experience in Quality Management, Quality Engineering, or Product Development Quality in medical devices (ISO 13485/MDSAP).
• Proven success in developing and implementing quality improvements and corrective actions.
• Ability to assess effectiveness of actions and establish preventive measures.
• Experience with CAPA, 8D, Root Cause Analysis (5 Why, Ishikawa).
• Strong statistical analysis and data-driven quality improvement skills.
• Fluent in English (written and spoken); additional languages are a plus.

Aufgaben

• Collaborate with R&D, Engineering, Manufacturing, and Regulatory Affairs to ensure safe, effective device designs.
• Maintain product risk management activities for assigned families.
• Ensure compliance with ISO 14971, ISO 13485, and regulatory requirements.
• Participate in risk assessments including Design and Process FMEAs.
• Monitor risk controls and drive continuous improvement.
• Plan, conduct, and document internal and external audits (front-office and back-office).
• Support ongoing maintenance and improvement of the QMS.
• Drive quality initiatives aligned with regulatory requirements and industry best practices.

Kenntnisse

Quality Management

CAPA

8D Problem Solving

Root Cause Analysis

Statistical analysis

English fluency

Ausbildung

Bachelor's degree in Engineering or Life Sciences

Master's degree preferred

Jobbeschreibung

Seeing beyond - future of medical technology

For more than 100 years, ZEISS medical technology has been driving progress in ophthalmology and microsurgery. In ophthalmology, our solutions help to maintain and improve people's vision at every stage of their lives. In microsurgery, our solutions enable targeted interventions on diseased tissue so that small and sensitive organs continue to function optimally. Medical technology from ZEISS supports medical professionals in improving the lives of patients worldwide. The fact that our actions have a direct impact on people's well-being is what drives us every day.

As a Quality Management Engineer, you will play a pivotal role in ensuring the safety, effectiveness, reliability, and regulatory compliance of innovative medical devices throughout their entire lifecycle. You will act as the quality representative within R&D projects, driving product quality, risk management, and compliance with global medical device regulations and standards.

Your role

Working closely with multidisciplinary teams including Research & Development, Engineering, Manufacturing, Regulatory Affairs, and external partners, you will contribute significantly to the development of next-generation medical technologies that improve patient outcomes and meet the highest quality standards.

• Close interdisciplinary collaboration to ensure safe, effective, and reliable medical device designs.
• Ensure process and regulatory compliance with the established product development process throughout all development stages
• Own and maintain product risk management activities for assigned product families
• Ensure compliance with ISO 14971 as well as 13485 and applicable regulatory requirements.
• Participate in and facilitate risk assessments, including Design and Process FMEAs.
• Monitor risk controls and evaluate their effectiveness as part of continuous product improvement activities.
• Plan, conduct, and document internal and external audits and perform both front-office and back-office audit activities.
• Support the systematic maintenance and continuous improvement of the Quality Management System (QMS).
• Drive quality improvement initiatives and ensure alignment with regulatory requirements and industry best practices.

Your Profile

• Bachelor's degree, Master's degree, or equivalent technical qualification in Engineering, Biomedical Engineering, Life Sciences, Quality Management, or a related discipline.
• Experience in Quality Management, Quality Engineering, or Product Development Quality, preferably within the medical device industry according to ISO 13485 and MDSAP requirements
• Proven experience in developing and implementing quality improvement measures and corrective actions.
• Demonstrated ability to assess effectiveness of implemented actions and establish preventive quality measures.
• CAPA, 8D Problem Solving, Root Cause Analysis (5 Why Methodology, Ishikawa (Fishbone) Analysis)
• Statistical analysis and data-driven quality improvement
• Fluent in English (written and spoken), additional languages are a plus

Temporary Position: This role is a parental leave cover and is therefore limited to a duration of 2 years.