Edwards Lifesciences Staff Supplier Quality Engineer in Salt Lake City, Utah
Provide quality engineering expertise and work closely with suppliers to ensure that the product or service received meets requirements and specifications. The Staff Supplier Quality Engineer will support site transfers, sustaining manufacturing processes, supplier validation, and supplier audits. This role will support all Draper Business Units.
Lead the transfer of receiving inspection and supplier quality activities of sustaining product lines from the Draper site to other Edwards network locations.
Support the start up to new Edwards Receiving Inspection locations, including equipment and training needs, validation support.
Use project management tools to establish transfer timelines and present project status to Sr Leadership.
Lead Supplier Notification of Change validation projects; manufacturing location change, material change, dual source suppliers.
Develop and validate inspection test methods for suppliers and Edwards.
Perform Supplier Audits to ISO13485 quality system requirements as a Lead Auditor.
Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
Train, coach, and guide lower level employees on more complex procedures
Bachelor's Degree in Engineering or Scientific field and a minimum of 6 years of experience.
Master's Degree or equivalent in Engineering or Scientific field and a minimum of 5 years of experience.
- Previous medical device industry experience, or experience in a regulated industry
• Ability to read and interpret drawings
• Proven expertise in statistical techniques
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Ability to translate technical information to all levels of the organizations
• Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
• Knowledge of Six Sigma concepts with ability to apply to work product
• Knowledge of Quality Engineering concepts with ability to apply to work product
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Extensive understanding of processes and equipment used in assigned work
• Strong leadership skills and ability to influence change
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Work is performed independently while exercising considerable latitude in making significant decisions
• Set policies and standards that are followed by others
• Guides others in resolving basic issues in specialized area based on existing solutions and procedures
• Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts
• Represents organization in providing solutions to difficult technical issues associated with specific projects
• 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
• Typically resolves complex problems or problems where precedent may not exist
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.