Edwards Lifesciences Staff Quality Engineer, Commercial Quality in Irvine, California
The Commercial Quality Staff Engineer will be working in a dynamic and fast paced environment. The individual is responsible for driving quality engineering processes and quality assurance activities as part of a cross functional team that includes: Sustaining R&D, Manufacturing, Operations, Regulatory Affairs, Marketing, Product Safety, etc. and other functions to drive technical decisions, product failure investigations, and project schedule associated with disposable and electronic products. This position will provide opportunities for advancement within our growing organization. We are looking for an individual who has strong technical and communication skills, initiative, and ability to work with cross functional teams.
Support Design Control activities for existing products.
Develop technical content of Risk Management Files. Manages and maintain Risk Management Documents (Risk Management Worksheet, FMEA's, Risk Management Plan and Report, etc.)
Support the investigation of product failures from complaints, CAPAs, Design Verification/Validation deviations, NCRs, and other quality related investigations.
Support Product Risk Assessment, Stop Shipments, RMCs, Quality Boards, FCAs.
Perform and support Design of Experiments, Test Method Validations, Equipment and Process Validations, analyzing data effectively and guide others in resolving basic issues in specialized area based on existing solutions and procedures.
Support all sustaining quality activities related to Receiving Inspection, In-process, Supplier, Contract Manufacturing, and field non-conformances.
Lead the team in the use quality systems and statistical techniques.
Oversee Quality support tasks, give instruction to engineers on conducting tests, analyzing data, train engineers and provide feedback.
Maintaining regulatory and quality compliance.
Knowledge and experience in Quality Systems, solutions, and processes.
Lead quality systems maintenance and improvement effort.
Willing to work in a dynamic environment to meet the needs of the business.
Train, coach, and guide lower level employees on more complex procedures.
Up to 25% travel
Required Education & Skills:
Bachelor’s in Engineering (Biomedical, Electrical, or Chemical) or Scientific field with a minimum 6 years of experience required, or a Master's Degree or equivalent in Engineering or Scientific field with 5 years including either industry or industry/education required, or a Ph.D. or equivalent in Engineering or Scientific field with 2 years including either industry or industry/education required.
Medical devices industry experience required.
Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering.
Proven expertise in statistical techniques.
Excellent documentation and communication skills and interpersonal relationship skills including relationship management skills.
A strong sense of urgency.
In-depth experience in Design Control and Sustaining Quality.
Advanced problem-solving, organizational, analytical and critical thinking skills. In-depth Root Cause analysis, quality and results oriented.
Strong leadership skills and ability to influence change.
Excellent team player.
Problem solving skills.
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 13,000 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.