Job Description
We are seeking a skilled Quality Engineer to maintain quality management systems and drive continuous improvement in our manufacturing processes.
Key Responsibilities:
1. Implement and maintain quality systems (ISO 13485, FDA, EU MDR) that meet regulatory requirements.
2. Analyze and improve manufacturing processes to enhance product quality and efficiency.
3. Conduct validation activities to ensure compliance with industry standards and regulations.
4. Perform risk assessments and implement mitigation strategies to minimize potential risks.
5. Analyze quality data and prepare reports to identify trends and areas for improvement.
6. Manage corrective and preventive actions to address quality issues and prevent future occurrences.
Qualifications:
1. Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred.
2. Minimum 3-5 years of experience in quality engineering, preferably in the medical device industry.
3. In-depth knowledge of ISO 13485, FDA regulations, and EU MDR.
4. Strong analytical, problem-solving, and communication skills to effectively collaborate with cross-functional teams.
5. Proficiency in quality management tools and software.
6. Fluent in English and German language proficiency is required.