About the Role: Imagine how your ideas and expertise can change a patient's life. Our Quality teams play a crucial role in shaping the development of innovative technologies, ensuring each stage of our innovation process meets the highest standards of integrity and safety.
Your Key Responsibilities:
* Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles.
* Analyze results, make recommendations and develop reports.
* Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
* Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
* Develop, update, and maintain technical content of risk management files.
* Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
What We Look For:
* Bachelor's Degree or Equivalent in an Engineering or Scientific field and 4 years min industry experience.
* Proven expertise in usage of MS Office Suite; CAD experience preferred.
* Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
* Working knowledge and understanding of statistical techniques.
* Previous experience working with lab/industrial equipment required.
You Will Thrive In This Role If:
* You have strong problem-solving, organizational, analytical and critical thinking skills.
* You understand and adhere to Quality systems.
* You are able to interact professionally with all organizational levels.
* You are able to manage competing priorities in a fast paced environment.