fective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle
- Utilize quality engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision
- Ensure effective risk management to prevent unanticipated failure modes and ensure capability
- Develop, implement, and maintain the appropriate Process Control Plan in alignment with Quality Plan
- Support of CAPA´s
- Functions as a project member in matters relating to Quality Engineering
- Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, statistical data analysis, statistical process control and development of sample plans
- Ensure effective change control
- Ensure active and thorough investigation of quality issues
- Support a state of inspection readiness
- Utilize the safety and environmental regulations of the facility
- The position can interact with outside organizations such as health authorities (https://e.g. FDA, ANVISA, etc.) and notified bodies (https://e.g. BSI)
- Performs other duties assigned as needed