Edwards Lifesciences Senior Manager - Quality Assurance in Shannon, Ireland
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 supervisors, managers, and/or experienced professionals and activities including quality control, exception handling, process audits to achieve release and compliance expectations. Drive quality culture and engage staff morale. Develop a robust talent development plan in alignment with functional growth strategies of the department.
• Plan and direct multiple complex quality assurance projects (e.g., CAPA) with the accountability for successful completion of all project deliverables to the business within established schedule, scope, and quality objectives. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups
• Negotiate solutions and reaching consensus with cross-functional groups to drive business line continuity and/or continuous improvement of quality assurance areas
• Responsible for inspection of in-process and finished goods, assemblies and components including proper implementation
• Interface with cross-functional teams (e.g., Manufacturing Operations, Supply Chain, and Engineering) to ensure tactical execution of business objectives
• Provide recommendations and implement workforce planning
• Lead efforts to optimize business processes and systems by assessing business needs and developing, proposing and implementing technology solution options.
• Act as a Subject Matter Expert (SME) in business processes in the area of responsibility. Define effective and efficient business process workflow, including process modifications in partnership with stakeholders
• Other incidental duties
Education and Experience:
Bachelor's Degree in a related field
Experience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices Required
Demonstrated track record in people management Required
Experience working in a regulated industry Preferred
• Proven successful project management leadership skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel and related 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 identifying applications of functional knowledge and existing methodologies to complex problems
• 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 one or more 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 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 internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
• Lead briefings and technical meetings for internal and external representatives
• Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
• 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.
• Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels
• 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 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.