Quality Assurance Engineer II
hace 2 días
Edwards Lifesciences is a global leader in patient-focused medical innovations, specializing in structural heart disease, critical care, and surgical monitoring. Our mission is to improve patient outcomes and enhance lives by collaborating with leading clinicians and researchers.
Job SummaryWe are seeking an experienced Engineering Lead - Quality Operations to join our team. This role will be responsible for supervising employees responsible for quality inspection, ensuring compliance with relevant requirements of the Quality Management System, and supporting ongoing improvement activities to improve Quality Systems.
Key Responsibilities:- Supervise employees and quality activities pertaining to product production and/or manufacturing processes, applying technical knowledge of 2 or more production areas.
- Develop and maintain sampling methods and procedures for inspections, testing, and evaluation, and support Quality Operations to guarantee product and process compliance.
- Support activities related to product risk evaluation for non-compliant distributed products and develop strategies for improvement.
- Partner with engineering on investigations and corrective actions, perform non-conformance investigations, and ensure documentation content validity.
- Oversee work order scheduling and team performance metrics, ensuring adequate staffing for all positions.
- Bachelor's Degree in Industrial Engineering, Business Administration, or related field required, with 2 years of experience or substantial technical knowledge and experience in assigned work area.
- Sufficient experience in related manufacturing, quality, medical device, pharmaceutical industry, and/or product development engineering, with skill levels exceeding previous experience requirements.
- Proven expertise in Microsoft Office Suite, Enterprise Resource Planning (ERP) system, preferably JDE, and excellent communication and interpersonal relationship skills.
- Full understanding of quality procedures, solid problem-solving, organizational, analytical, and critical thinking skills, and robust understanding of processes and equipment used in assigned work.
We are committed to helping patients regain and improve the quality of their life through innovative medical technologies. Our collaborative approach with clinicians and researchers drives us to address unmet healthcare needs and push boundaries in patient-focused medical innovations.
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