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About the Role

As a Quality Management Engineer, you will ensure the safety, effectiveness, reliability, and regulatory compliance of innovative medical devices throughout their 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.

Responsibilities

Act as the quality representative within R&D projects.
Drive product quality, risk management, and compliance with global medical device regulations and standards.
Contribute to the development of next-generation medical technologies.
Ensure safe, effective, and reliable medical device designs through close interdisciplinary collaboration.
Ensure process and regulatory compliance with the established product development process.
Own and maintain product risk management activities for assigned product families.
Ensure compliance with ISO 14971, ISO 13485, and applicable regulatory requirements.
Participate in and facilitate risk assessments, including Design and Process FMEAs.
Monitor risk controls and evaluate their effectiveness.
Plan, conduct, and document internal and external audits.
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.

Requirements

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.
Experience with CAPA, 8D Problem Solving, Root Cause Analysis (5 Why Methodology, Ishikawa (Fishbone) Analysis).
Experience with statistical analysis and data-driven quality improvement.
Fluent in English (written and spoken).
This role is a parental leave cover and is limited to a duration of 2 years.

Skills

Quality Management
Quality Engineering
Product Development Quality
ISO 13485
MDSAP
Risk Management
ISO 14971
CAPA
8D Problem Solving
Root Cause Analysis
5 Why Methodology
Ishikawa (Fishbone) Analysis
Statistical analysis
Data-driven quality improvement

Work Type

Temporary Position

Education Level

Bachelor's degree
Master's degree

About the Company

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.