1. Quality Assurance Processes
2. Supplier Management
3. Manufacturing Support
4. Corrective and Preventive Actions (CAPA)
5. Post-Market Surveillance
6. Training and Documentation
Requirements: - Bachelor's degree in engineering, life sciences, or a related field. A master's degree is a plus
- Proven experience (typically 2+ years) in quality engineering or a related role, preferably in the medical device industry.
- Strong knowledge of quality management systems, regulatory requirements (e.g., CE, FDA, ISO 13485), and relevant industry standards.
- Familiarity with design control principles and experience in participating in design reviews.
- Solid understanding of manufacturing processes, quality control methods, and statistical techniques.
- Experience in conducting root cause analysis, risk assessments, and implementing corrective and preventive actions (CAPAs).
- Excellent problem-solving skills and the ability to analyze complex situations and make sound decisions.
This position is open to all candidates.
