Mgr SQ Supply Base Optimization

h3Job Function /h3pQuality /ph3Job Sub Function /h3pSupplier Quality /ph3Job Category /h3pPeople Leader /ph3All Job Posting Locations /h3pPalm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Ringaskiddy, Cork, Ireland, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America, Zuchwil, Switzerland /ph3Job Description /h3h3SECTION 1: JOB SUMMARY /h3pThe Manager Source Quality Supply Base Optimization is a people leader responsible for leading, developing, and deploying a team of Supplier Quality Engineers in support of MedTech supply base optimization strategies and programs. The position provides strategic, technical, and organizational leadership for Source Quality activities associated with supplier selection, qualification, development, product and process transfers, supplier consolidation, supplier exits, stabilization, and transition to base business. /ppThe Manager Source Quality Supply Base Optimization establishes team priorities, assigns resources, manages performance and development, builds organizational capability, and ensures consistent execution of applicable Quality System and Purchasing Controls requirements. The position partners with Source Quality, Procurement, Network Optimization, Supply Chain, Manufacturing, Engineering, Regulatory, Quality Systems, and other business partners to achieve patient safety, product quality, compliance, supply continuity, productivity, and business objectives. /ppThis position serves as the primary Source Quality leader for assigned Supply Base Optimization programs and is accountable for effective quality and regulatory engagement from business-case development through project implementation, stabilization, and transition to sustaining ownership. /ph3SECTION 2: DUTIES RESPONSIBILITIES /h3h3People Leadership and Organizational Capability /h3ulliLead, manage, coach, and develop a team of Supplier Quality Engineers and, where applicable, contracted resources supporting Supply Base Optimization programs and initiatives. /liliEstablish clear roles, objectives, priorities, performance expectations, and accountability for team members. /liliTranslate business and portfolio priorities into resource plans, assignments, development plans, and measurable team deliverables. /liliConduct regular performance and development discussions, provide timely coaching and feedback, recognize strong performance, and address performance or capability gaps in accordance with Company processes. /liliBuild technical, quality, project-management, leadership, and business capabilities across the team through targeted development plans, mentoring, training, stretch assignments, and knowledge sharing. /liliSupport workforce planning, talent reviews, succession planning, recruiting, onboarding, retention, and career development for the Supplier Quality Engineering team. /liliCreate an inclusive, collaborative, accountable, and high‑performing team environment that enables employees to contribute effectively across a global, matrixed organization. /liliBalance team capacity and demand, assign qualified resources to projects based on risk and business priority, and escalate resource constraints or capability gaps when needed. /liliEnsure team members maintain required training, qualifications, and technical competencies and consistently execute work in compliance with applicable Quality System requirements. /liliProvide technical and leadership guidance for complex supplier quality, compliance, transfer, validation, and risk‑management matters. /liliEnsure effective delegation, decision‑making, communication, and escalation within the team. /liliMaintain accountability for team performance, project execution, quality outcomes, budget or contractor oversight where applicable, and delivery of agreed business results. /li /ulh3Product and Process Transfer Strategy Execution and Program Management /h3ulliLead the Source Quality function for Supply Base Optimization projects, including supplier‑related product and process transfers, supplier consolidation, supplier exits, and other network optimization initiatives. /liliProvide technical leadership in quality, compliance, supplier controls, risk management, process validation, and transfer execution. /liliLead development and execution of Transfer Quality Plans and associated product, process, supplier‑development, qualification, stabilization, and transition strategies. /liliAssign and oversee Supplier Quality Engineering resources supporting projects and ensure clear ownership of deliverables, milestones, risks, issues, and decisions. /liliLead quality and compliance risk‑management activities and ensure risks are identified, documented, escalated, mitigated, and monitored. /liliEnsure compliance with applicable requirements for design change control, process change control, validation, purchasing controls, supplier qualification, product and process transfers, and change management. /liliAssess the suitability and maturity of supplier quality systems, manufacturing processes, technical capabilities, and controls for the products and processes being transferred. /liliConfirm, analyze, and review quality, compliance, operational, and performance history for new and existing suppliers. /liliLead or oversee supplier onboarding, qualification, development, technical assessments, quality planning, and stabilization activities. /liliPartner with relevant Quality and Compliance functions to ensure appropriate engagement, review, approval, and escalation. /liliLead or oversee investigation, escalation, containment, corrective action, and risk reduction for significant quality issues associated with Supply Base Optimization projects. /liliEnsure project team members are trained in relevant procedures, strategies, standard work, tools, and quality requirements. /liliMaintain effective stakeholder communication and provide concise updates regarding project status, quality and compliance risks, resource needs, decisions, and required actions. /liliEstablish and monitor project dashboards and metrics for schedule, quality, compliance, supplier performance, risk, financial performance, and stabilization. /liliMonitor transferred products and processes through stabilization to verify performance, effectiveness of controls, and readiness for transition to sustaining ownership. /liliProvide program‑management‑office updates and reporting, including schedule, resources, financials, risks, dependencies, benefits, and Quality and Compliance key performance indicators. /liliLead closure of Supply Base Optimization transfer documentation and ensure complete, accurate, timely, and compliant project records. /liliEnsure Purchasing Controls and Quality System requirements are effectively implemented during supplier selection, Approved Supplier List activities, product and component qualification, process and product transfer, supplier quality agreement development, receiving inspection planning, and stabilization. /liliEnsure decisions appropriately protect patient safety, product quality, regulatory compliance, and continuity of supply. /li /ulh3Supply Base Strategy, Governance, And Standard Work /h3ulliPartner with Procurement, Network Optimization, Supply Chain, Quality and Compliance, Engineering, Manufacturing, and other functions to develop Supply Base Optimization strategies and project plans. /liliDefine Source Quality resource, communication, stakeholder, and change‑management plans for Supply Base Optimization projects and portfolios. /liliEstablish Transfer Quality Plans and related strategies and translate quality requirements into project scope, resources, cost, schedule, risk, and execution implications. /liliAssess project interdependencies and align Source Quality priorities across related business, Quality and Compliance, supplier, and network initiatives. /liliEstablish governance mechanisms, management routines, decision forums, escalation pathways, and portfolio reviews for Source Quality Supply Base Optimization activities. /liliDevelop, deploy, and sustain standard work, procedures, forms, checklists, playbooks, tools, templates, and knowledge resources for supplier transfers, supplier development, supplier exits, decommissioning, commissioning, quality financials, and stabilization. /liliMaintain effective Quality Management System interfaces for product and process transfer procedures across applicable businesses and franchises. /liliIdentify opportunities to simplify, standardize, digitize, and continuously improve Source Quality processes and team effectiveness. /liliTrack performance, lessons learned, and leading indicators and use the information to improve future project planning, supplier decisions, resource allocation, and risk controls. /liliRepresent Source Quality in cross‑functional governance forums and communicate business‑related risks, issues, opportunities, decisions, and resource needs to the appropriate management level. /li /ulh3SECTION 3: EXPERIENCE AND EDUCATION /h3ulliA bachelor’s degree or equivalent in Engineering, Science, Quality, Regulatory, Supply Chain, Business, or a related discipline is required. An advanced degree is preferred. /liliA minimum of eight years of progressive experience in Quality, Supplier Quality, Engineering, Manufacturing, Supply Chain, Program Management, or a related discipline within the medical device, pharmaceutical, combination‑product, or another highly regulated industry is required. /liliA minimum of two years of direct people‑management experience is required, including demonstrated responsibility for goal setting, performance management, coaching, employee development, talent planning, and resource allocation. /liliDemonstrated experience leading and developing technical professionals, preferably Supplier Quality Engineers, in a global or matrixed organization is required. /liliDemonstrated experience leading complex supplier‑related product or process transfers, supplier qualification, supplier development, external manufacturing, supplier consolidation, supplier exits, or network optimization initiatives is required. /liliIn‑depth knowledge of quality and manufacturing systems, supplier controls, purchasing controls, process validation, change control, risk management, and applicable regulatory requirements is required. /liliWorking knowledge of ISO 13485, European Union Medical Device Regulation requirements, applicable United States medical‑device quality‑system requirements, and current good manufacturing practices is required. /liliExperience managing multiple projects, priorities, resources, and stakeholders and delivering results through both direct authority and cross‑functional influence is required. /liliExperience with financial planning, business cases, resource planning, portfolio prioritization, and program governance is preferred. /li /ulh3SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS /h3ulliDemonstrated people‑leadership capability, including coaching, feedback, performance management, talent development, succession planning, change leadership, and team building. /liliAbility to create clarity, accountability, engagement, and alignment within a technical team operating in a complex, global, matrixed environment. /liliStrong technical credibility in Supplier Quality, Quality Engineering, supplier controls, process validation, risk management, and product and process transfer. /liliStrong program and project‑management capability, including governance, planning, resource management, risk management, decision‑making, escalation, and executive reporting. /liliStrong business and financial acumen and the ability to translate quality and compliance requirements into practical business, resource, schedule, and risk implications. /liliAbility to prioritize and deploy resources based on patient, product, compliance, supply, and business risk. /liliDemonstrated ability to influence senior leaders, cross‑functional partners, technical experts, and supplier executives. /liliStrong communication, facilitation, negotiation, conflict‑resolution, and stakeholder‑management skills. /liliStrong analytical, problem‑solving, and data‑driven decision‑making skills. /liliExperience with Lean, Six Sigma, Process Excellence, or structured problem‑solving methods is required. /liliProject‑management certification or formal project‑management training is preferred. /liliCQM, CQA, CQE, CSQP, or an equivalent quality certification is preferred. /liliAbility to operate effectively in a fast‑paced environment, manage ambiguity, and lead through organizational and business change. /li /ulh3Required Skills /h3ulliCompliance Management /liliContinuous Improvement /liliDeveloping Others /liliInclusive Leadership /liliLeadership /liliOperations Management /liliPerformance Measurement /liliProduct Testing /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliQuality Validation /liliRelationship Building /liliRisk Management /liliStandard Operating Procedure (SOP) /liliTeam Management /liliVendor Selection /li /ulh3Preferred Skills /h3ulliCompliance Management /liliContinuous Improvement /liliDeveloping Others /liliInclusive Leadership /liliLeadership /liliOperations Management /liliPerformance Measurement /liliProduct Testing /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliQuality Validation /liliRelationship Building /liliRisk Management /liliStandard Operating Procedure (SOP) /liliTeam Management /liliVendor Selection /li /ulh3The anticipated base pay range for this position is : /h3p$102,000.00 - $177,100.00 /ph3Additional Description For Pay Transparency /h3pSubject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). /ppThis position is eligible to participate in the Company’s long‑term incentive program. /ph3Benefits /h3ulliVacation –120 hours per calendar year /liliSick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year /liliHoliday pay, including Floating Holidays –13 days per calendar year /liliWork, Personal and Family Time - up to 40 hours per calendar year /liliParental Leave – 480 hours within one year of the birth/adoption/foster care of a child /liliBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year /liliCaregiver Leave – 80 hours in a 52‑week rolling period10 days /liliVolunteer Leave – 32 hours per calendar year /liliMilitary Spouse Time-Off – 80 hours per calendar year /li /ulpFor additional general information on Company benefits, please go to: - /p #J-18808-Ljbffr