The Staff Quality Engineer applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. The Quality Engineer (QE) will focus on design control, design verification/validation failure analysis, FMEA, specification development, statistical reliability, quality/process control, acceptance sampling, and inspection/test methodologies. Will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
Critical review and approval of design changes, partner with R&D in the design of safe and effective THV device.
Partner with Manufacturing Engineers to develop critical manufacturing processes and provide technical quality support for the pilot production of clinical devices.
Root cause analysis investigation for component and device non-conformances.
Develop technical content of risk management files.
Managing purchased component quality issues and working directly with suppliers.
Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
Provide technical quality support for design qualifications, design transfer, activities for Regulatory submissions, development and implementation of design control documents, presentations for design reviews, and approval of product/process changes.
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
A Bachelor of Science degree in Mechanical, Biomedical, or equivalent engineering degree is required.
Minimum of 6 years’ experience in Quality or Manufacturing is required.
Knowledge of equipment qualification and design verification in the medical device industry or other regulated industries is required.
ASQ Certified Quality Engineer (CQE) preferred with knowledge of Six Sigma concepts.
Thorough knowledge of ISO design control regulations and FDA design Control QSRs.
Working experience in medical device design control.
Strong working understanding of failure analysis, FMEA, specification development, quality/process control, acceptance sampling, and inspection/test methodologies.
Extensive knowledge and understanding of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge).
Working knowledge and understanding of statistical techniques, reliability, and acceptance sampling.
Develops technical solutions to complex problems which require the regular use of creativity.
Uses best practices and knowledge of internal or external business issues to improve products/services or processes.
Ability to manage competing priorities in a fast-paced environment.
Must be able to work effectively and collaborate within cross functional teams.
Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
Typically resolves complex problems or problems where precedent may not exist.
Advanced problem-solving, organizational, analytical and critical thinking skills.
Strong leadership skills and ability to influence change.
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, Californi...a, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.