Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
The Role
Manage team to ensure smooth and continuous operations of site quality system, quality control and assurance inspection for in process and finished goods. Oversee process audits and final product release documentation. Advise and facilitate failure investigations, compliance methodologies for manufacturing of valve assemblies 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.
How Will You Make an Impact?
- Manage supervisors and/or oversee the work of assigned quality assurance team within own function, one or more production line or projects. Develop a robust talent development plan in alignment with functional growth strategies of the department. Identify opportunities and lead the implementation of changes to drive improvements
- Manage quality assurance project activities (e.g., CAPA) with the accountability for successful completion of all deliverables to the business within established schedule, scope and quality objectives. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional groups
- Collaborate with cross-functional groups to manage inspection of in-process and finished goods, assemblies and components including proper implementation
- Negotiate solutions with cross-functional groups (e.g., Manufacturing Operations, Supply Chain, and Engineering) for continuous improvement
- Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes. 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 assigned 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
- Provide technical guidance to cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity
- Lead the implementation of CAPA program including training, approvals, and system effectiveness
What You Will Need?
- Bachelor's Degree in in Science or Engineering field previous related experience Required
- Experience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices or equivalent work experience based on Edwards criteria
- Demonstrated track record in people management or equivalent work experience based on Edwards criteria
- Experience working in a regulated industry or equivalent work experience based on Edwards criteria
What Else We Require?
- Proven successful project management leadership skills
- Proven expertise in both Microsoft Office Suite, including advanced Excel and related quality systems
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Expert understanding of quality procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
- Expert understanding of related aspects of quality processes and/or systems
- Expert knowledge of financial acumen as it relates to quality
- Expert knowledge of applicable quality regulations (e.g., cGMP compliance)
- Demonstrated ability to manage assigned 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 develop and integrate metrics into the projects and operations that clearly demonstrate the value of 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
- Knowledge of Lean Manufacturing concepts and Six Sigma
- 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
- Proven successful project management leadership skills
- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
- Expert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
- Expert understanding of related aspects of quality engineering processes and/or systems
- Expert 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
- Knowledge of financial acumen as it relates to the business as well as quality engineering
