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About the Role
The Senior Quality Assurance Engineer will play a key role in ensuring the quality and reliability of our products and processes at ALOIS Solutions. This position requires a strong understanding of quality engineering principles and practices, as well as excellent project management and leadership skills.
Key Responsibilities
- New Product/Process Introduction
- Collaborate with cross-functional teams to ensure the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
- Business Improvements
- Support quality improvement initiatives, such as process and product characterizations, to drive continuous and cost improvements.
- Conduct benchmarking to develop more effective methods for improving quality.
- Develop and implement quality engineering and compliance strategies for new product introductions and product life cycle management.
- Qualifications
- A minimum of a Bachelor's Degree in Engineering or a related technical field.
- Experience working in a regulated environment, preferably with FDA and European regulatory knowledge.
- Strong knowledge of risk management principles, including FDA and ISO standards.
- Experience with statistical software packages and the ability to analyze and present data to drive decision-making.
- Proven project management and leadership skills.