Edwards Lifesciences Supplier Quality Engineering Manager, Transcatheter Mitral and Tricuspid Therapies in Irvine, California
Edwards Lifesciences has an opening for a Supplier Quality Engineering Manager who will be a part of our growing Transcatheter Mitral and Tricuspid Therapies (TMTT) team in Irvine, CA. We are looking for a strong leader with solid technical expertise, who enjoys working in a fast-paced and rapidly growing environment. The quality leader is responsible for overseeing qualification activities for suppliers and components being introduced as part of new product develop programs in the TMTT business unit.
• Provide oversight and mentorship for supplier quality engineers who are responsible for working with new product development teams and supplier development engineers on integrating new components and suppliers into the Edwards quality system. The supplier quality engineers currently support component specification development, identification of critical features, development of inspection methods and plans, test method validation, component capability assessment, and validation of outsourced critical processes.
• Manage investigation, containment, and risk-based escalation (as appropriate) of nonconformance issues identified for purchased pre-commercial components.
• Ensure supplier files associated with the suppliers utilized on new products comply with Edwards supplier qualification requirements.
• Identify supplier quality engineering resource requirements and manage deployment of resources to provide coverage for the new product development programs within TMTT.
• Lead continuous improvement initiatives, including quality system and procedure adjustments, to elevate quality, compliance, and efficiency of the supplier qualification process.
• Manage personnel ensuring growth and professional development.
• Bachelor's degree in engineering required; with a minimum of 8 years of experience with comparable responsibilities.
• Previous experience in supplier quality or product development in medical devices.
• Knowledge of the FDA’s Quality System Regulations; experience working within a Quality Management System.
• Previous supervisory experience.
• Ability to prioritize, plan & evaluate deliverables to established strategic goals.
• Strong management and leadership skills to ensure management, growth and development of personnel.
• Excellent verbal and written communication and presentation skills with the ability to communicate business issues in an easy to understand manner.
• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.
• Strong problem solving, influencing and negotiation skills, ability to work well as a leader, independently and in a team setting.
• Strong working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD 93/42/EEC and other applicable regulatory requirements.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.