Job DescriptionManage team with responsibility of the development, direction, coordination, evaluation and compliance of the Supplier Quality Program.
How you will make an Impact: Manage supplier management project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives utilizing lean manufacturing and error proofing. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups.Manage and/or oversee the work of a supplier quality team within own function and/or cross functional project teams and may have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department.Identify risk, develop and lead in the implementation of supplier quality strategies which may include negotiations with internal and external parties.Lead the implementation of quality agreements with suppliers that include requirements for component specifications that details control requirements such as component's CTQs (Critical to Quality), control plans, SPC (statistical Process Controls) and other continual improvement tools.Perform complex quality trend analysis from supplier base and facilitate corrective actions as appropriate.Assess supplier performance against contractual obligations, scorecards and key performance indicators.Other incidental duties. What you will need: Bachelor's Degree in related field and related experience in engineering Required.
Regulatory experience in International Standards ISO-9001:2008, ISO-13485:2003 and 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR) Required.
Demonstrated track record in management of technical and/or engineering disciplines Required.
Experience in managing a major transformational change program, developing and exercising sound change management and communication plans Required.
Experience working in a regulated industry Preferred.
What else we look for: Proven successful project management leadership 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 written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.Expert understanding of supplier quality procedures while addressing issues with impact beyond own team based on knowledge of related disciplines.Expert understanding of related aspects of supplier quality processes and/or systems.Expert knowledge of state-of-the-art inspection and quality inspection and quality engineering/assurance techniques, instruments, equipment, theories, principles and concepts and general business operations.Expert knowledge using Lean and 6-sigma tools.Knowledge of financial acumen as it relates to the business as well as supplier quality.Demonstrated ability to direct teams 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 develop and integrate metrics into the projects and operations that clearly demonstrate the value of supplier quality to the business.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.Frequently interacts with subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team.Participate and present at meetings with internal and external representatives.Resolve operational and scheduling issues.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.Develop relationships and leverage them to influence change.Support and solicit input from team members at all levels within the organization.Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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. About UsEdwards 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.
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