My client is a leader in the medical device industry, dedicated to enhancing patient care with high-quality products and innovative technology.
Position Summary: We are seeking a skilled Quality Engineer to maintain quality management systems and drive continuous improvement in our manufacturing processes.
Key Responsibilities:
1. Quality Management: Implement and maintain quality systems (ISO 13485, FDA, EU MDR).
2. Process Improvement: Analyze and improve manufacturing processes to enhance quality.
3. Validation: Conduct validation activities to ensure compliance.
4. Risk Management: Perform risk assessments and implement mitigation strategies.
5. Data Analysis: Analyze quality data and prepare reports.
6. CAPA Management: Manage corrective and preventive actions.
Qualifications:
1. Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred.
2. 3-5 years of experience in quality engineering, preferably in medical devices.
3. Knowledge of ISO 13485, FDA regulations, and EU MDR.
4. Strong analytical, problem-solving, and communication skills.
5. Proficiency in quality management tools.
6. Fluent in English and German.
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