My client are 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:
- Quality Management: Implement and maintain quality systems (ISO 13485, FDA, EU MDR).
- Process Improvement: Analyze and improve manufacturing processes to enhance quality.
- Validation
- Risk Management: Perform risk assessments and implement mitigation strategies.
- Data Analysis: Analyze quality data and prepare reports.
- CAPA Management
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred.
- 3-5 years of experience in quality engineering, preferably in medical devices.
- Knowledge of ISO 13485, FDA regulations, and EU MDR.
- Strong analytical, problem-solving, and communication skills.
- Proficiency in quality management tools.
- Fluent in English and German.
