Manage Quality Engineers for ICU Medical, ensuring compliance and effective QA for electromechanical products. Lead product development, quality management systems, and lifecycle management.
Responsibilities
Provide effective tactical Quality leadership for Quality Engineers
Interact and communicate with Senior Leadership across ICU Medical regarding program status, risks, mitigation plans and business objectives
Deploy and assure compliance with ICU Medical’s Quality System such as Design Controls, risk analysis/management tools, design verification, design validation, investigations, CA/PA data, etc.
Support design and manufacturing site inspections/audits
Assure systems conform to all applicable US and international regulatory requirements
Ensure all Quality attributes for design changes and fixes are met
Define, evaluate, prioritize and correct potential product and process risks to drive continuous quality improvements
Requirements
Bachelor’s degree in Mechanical Engineering, Bio Engineering, Materials Science, or Physics required
8 years of regulated industry experience required, preferably in a quality or compliance position of technical quality assurance experience in a related field
2 - 4 years of management or supervisory experience
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