Edwards Lifesciences Quality Engineer I, Quality in Salt Lake City, Utah
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. Please refer to the job description for additional details.
Investigate basic manufacturing product quality and compliance issues (e.g, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
Optimize Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
May develop, update, and maintain technical content of risk management files.
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinates technician work.
Other incidental duties assigned by Leadership.
Education and Experience:
Bachelor's Degree or equivalent in in Engineering or scientific field, 0 years years experience related work experience Required Or
Master's Degree or equivalent in in Engineering or scientific field, 0 years years experience related work experience Preferred.
Good computer skills in usage of MS Office Suite; CAD experience preferred.
Basic documentation, communication and interpersonal relationship skills.
Basic understanding of statistical techniques.
Previous experience working with lab/industrial equipment preferred.
Good understanding and knowledge of principles, theories, and concepts relevant to Engineering.
Good problem-solving, organizational, analytical and critical thinking skills.
Good understanding of processes and equipment used in assigned work.
Knowledge of and adherence to Quality systems.
Strict attention to detail.
Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fast paced environment.
Must be able to work in a team environment, including immediate supervisor and other team members in the section or group.
Ability to build stable working relationships internally.
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.