Senior Manager, QE & QA (Metals)

The RoleManage 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?Quality representative for Metals associated with internal and external audits. Coordinate with Ireland Quality Systems Management for audit preparation, execution and action plans. Ensure Metals Organization executes to Ireland quality objectives/plans.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 improvementsManage 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 including training, approvals, and system effectiveness. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional groupsCollaborate with cross-functional groups to manage inspection of in-process and finished goods, assemblies and components including proper implementationNegotiate solutions with cross-functional groups (e.g., Manufacturing Operations, Supply Chain, and Engineering) for continuous improvementManage 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 groupsManage 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 departmentProvide 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. Collaborate with Campus Model shared services to support Ireland Metals Organization.Other incidental dutiesWhat You Will Need?Bachelor's Degree in Science or Engineering fieldExperience 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 criteriaDemonstrated track record in people management or equivalent work experience based on Edwards criteriaExperience working in a regulated industry or equivalent work experience based on Edwards criteriaWhat Else We Require?Proven successful project management leadership skillsProven expertise in both Microsoft Office suite, including advanced Excel and related quality systemsExcellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectivesExpert understanding of quality procedures while addressing issues with impact beyond own team based on knowledge of related disciplinesExpert understanding of related aspects of quality processes and/or systemsExpert knowledge of financial acumen as it relates to qualityExpert 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 relationsAbility to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality to the businessStrict attention to detailAbility to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organizationAbility to work and excel within a fast paced, dynamic, and constantly changing work environmentKnowledge of Lean Manufacturing concepts and Six SigmaFrequently 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 teamParticipate and present at meetings with internal and external representativesResolve operational and scheduling issuesDedicated 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 changeSupport and solicit input from team members at all levels within the organizationAdhere 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/controlProven successful project management leadership skillsExcellent problem solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision makingExpert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplinesExpert understanding of related aspects of quality engineering processes and/or systemsExpert 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 ManufacturingKnowledge of financial acumen as it relates to the business as well as quality engineering