Edwards Lifesciences Associate Manager, Supplier Quality Engineering in Salt Lake City, Utah
Manage team with activities that focus on implementing and optimizing quality engineering practices while ensuring a culture of quality and compliance with global regulatory requirements.
• Manage and/or lead a small team within Supplier Quality Engineering. Develop team members to increase business acumen and functional skills
• Work on complex supplier and production issues where analysis of issues requires in-depth knowledge of production processes and quality systems.
• Plan and direct assigned operational and project activities with the accountability for successful completion of assigned deliverables
• Identify opportunities internally and at suppliers to lead the implementation of changes to drive improvements.
• Oversee engineering tasks; provide technical guidance and feedback to technicians/engineers; Guide lower level employees on more complex procedures
• Create/update complex engineering documents including requirement specs, and risk documents with robust knowledge on design control requirements
• Collaborate with cross-functional teams to lead the implementation of NCR, SCAR, CAPA, and NOC program including training, approvals, and system effectiveness.
Manage supplier audit schedule and execute supplier audits.
Visit suppliers to perform audits, RCCA, and improvement projects.
• Other incidental duties
Education and Experience:
• Bachelor's Degree in related field and 6 years of related experience in engineering Required
• Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry Required
• Experience working in a regulated industry Preferred
• Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills
• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite and related systems
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Extensive understanding of engineering procedures while defining team operating standards
• Extensive understanding of related aspects of quality engineering processes and/or systems
• Extensive knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)
• Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing
• Basic financial acumen as it relates to quality engineering
• Demonstrated skill set to manage small team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Ability to influence cross-functional partners
• Ability to integrate metrics into the projects and operations
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Primarily interacts with internal subordinates and other supervisors
• Typically interacts with external suppliers, vendors and/or customers
• Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
• Dedicated to quality client service and pro-active and responsive to client needs.
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• 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 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.