SECTION 3: EXPERIENCE AND EDUCATION*
· A bachelor’s degree or equivalent in Engineering, Science, Quality, Regulatory, Supply Chain, Business, or a related discipline is required. An advanced degree is preferred.
· A 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.
· A 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.
· Demonstrated experience leading and developing technical professionals, preferably Supplier Quality Engineers, in a global or matrixed organization is required.
· Demonstrated 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.
· In-depth knowledge of quality and manufacturing systems, supplier controls, purchasing controls, process validation, change control, risk management, and applicable regulatory requirements is required.
· Working 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.
· Experience managing multiple projects, priorities, resources, and stakeholders and delivering results through both direct authority and cross-functional influence is required.
· Experience with financial planning, business cases, resource planning, portfolio prioritization, and program governance is preferred.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS***
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Demonstrated people-leadership capability, including coaching, feedback, performance management, talent development, succession planning, change leadership, and team building.
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Ability to create clarity, accountability, engagement, and alignment within a technical team operating in a complex, global, matrixed environment.
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Strong technical credibility in Supplier Quality, Quality Engineering, supplier controls, process validation, risk management, and product and process transfer.
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Strong program and project-management capability, including governance, planning, resource management, risk management, decision-making, escalation, and executive reporting.
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Strong business and financial acumen and the ability to translate quality and compliance requirements into practical business, resource, schedule, and risk implications.
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Ability to prioritize and deploy resources based on patient, product, compliance, supply, and business risk.
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Demonstrated ability to influence senior leaders, cross-functional partners, technical experts, and supplier executives.
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Strong communication, facilitation, negotiation, conflict-resolution, and stakeholder-management skills.
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Strong analytical, problem-solving, and data-driven decision-making skills.
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Experience with Lean, Six Sigma, Process Excellence, or structured problem-solving methods is required.
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Project-management certification or formal project-management training is preferred.
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CQM, CQA, CQE, CSQP, or an equivalent quality certification is preferred.
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Ability to operate effectively in a fast-paced environment, manage ambiguity, and lead through organizational and business change.