General Manager; Quality Systems & Governance
hace 4 días
Melville
The General Manager, Quality Systems & Governance owns and continuously improves the Nikon Instruments Inc. Quality Management System and serves as the company-wide catalyst for clear process ownership, accountability, evidence, corrective-action closure, and operational effectiveness. The position reports directly to the President & CEO to preserve independence and carries authority to convene functions, require documented responses, issue QMS and governance findings, assign response deadlines through accountable leaders, and escalate unresolved material risks. The role combines independent QMS leadership with a limited enterprise-governance and continuous-improvement mandate. It does not assume operational ownership of the functions it reviews. Functional and Process Owners remain accountable for business decisions, control execution, performance management, and implementation of approved corrective actions. ESSENTIAL FUNCTIONSAND KEY AREAS OF RESPONSIBILITY: Quality Management System Leadership • Own the NII Quality Manual, QMS framework, policies, procedures, and performance-monitoring system., • Maintain alignment with applicable Nikon requirements and quality standards, including ISO 9001:2015., • Define the annual QMS plan, priorities, resources, metrics, and improvement roadmap., • Evaluate QMS effectiveness and recommend changes to the President & CEO and Management Review. Audit, CAPA, and Quality Risk • Develop and administer a risk-based internal-audit program; coordinate external, Nikon, customer, and regulatory audits and responses., • Own finding governance, including clear owners, due dates, evidence requirements, escalation, effectiveness review, and verified closure., • Administer CAPA and quality-risk processes and escalate overdue, ineffective, repeated, or materially unresolved actions., • Ensure the role does not audit its own work: independent review of QMS-process effectiveness will be performed by qualified independent personnel, Internal Audit, or external auditors. Document, Record, and Training Governance • Own controlled-document requirements covering authorship, approval, release, change, access, retention, periodic review, and obsolescence., • Confirm that significant processes have current SOPs or work instructions, named owners, required records, and usable evidence., • Define QMS training governance and confirm departments maintain training plans, skill maps, competency records, and completion evidence., • Lead selection and improvement of document-management and eQMS workflows; strong use of SharePoint or equivalent platforms is expected. Management Review and Executive Reporting • Coordinate Management Review inputs and outputs, including audit status, CAPA, quality trends, process performance, risks, decisions, and actions., • Maintain a concise executive dashboard of quality, governance, action aging, recurrence, and closure effectiveness., • Provide direct, neutral escalation to the President & CEO for material quality, compliance, governance, or internal-control concerns., • Retain auditable evidence of management oversight, decisions, action ownership, and follow-through. Cross-Functional Process Governance • Facilitate definition and periodic review of Process Owners, decision authority, cross-functional RACI matrices, handoffs, approvals, records, and escalation paths for significant processes., • Identify unclear ownership, conflicting responsibilities, missing procedures, insufficient evidence, ineffective handoffs, and excessive key-person dependency., • Require accountable leaders to provide documented remediation plans and monitor approved actions to verified closure., • Act as a neutral referee on quality-system and governance design; unresolved accountability disputes are escalated to the President & CEO. Product, Service, and Supplier Quality Governance • Monitor defined development, launch, change-control, release, service-quality, and post-launch review processes for required gates, approvals, validation evidence, feedback, and lessons learned., • Coordinate QMS requirements for workflows spanning Product & Development, Customer Success, Service, Business Planning, Sales, Operations, Legal, HR, IT, and NBIL., • Support supplier qualification, supplier-quality review, investigations, corrective actions, and retained evidence while purchasing and commercial decisions remain with the responsible functions., • Support significant product and service quality investigations without taking over technical disposition or operational execution. Continuous Improvement and Operational Effectiveness • Establish a practical continuous-improvement framework aligned with company objectives and KPIs., • Use process mapping, data analysis, root-cause analysis, Lean, Six Sigma, Kaizen, or comparable methods when appropriate to the business need., • Maintain a prioritized portfolio of cross-functional improvement initiatives with defined scope, owner, milestones, expected benefit, risks, and results., • Measure benefits realization across quality, customer experience, productivity, cost, cycle time, and risk reduction, while avoiding over-engineering. Change Leadership and Capability Building • Partner with functional leaders to implement and sustain approved process changes, communication plans, and training., • Coach Process Owners and managers in problem solving, evidence discipline, CAPA, risk-based thinking, and effective control design., • Develop internal auditor, QMS representative, and continuous-improvement capability across the company., • Promote a culture in which concerns are raised early, decisions are documented, and actions remain open until effectiveness is verified. Decision and Escalation Authority Approves • QMS procedures, document-control standards, audit plans, audit reports, CAPA-governance requirements, and quality-system reporting within approved policy., • QMS finding classification, evidence requirements, closure criteria, and effectiveness-review conclusions., • QMS training requirements and internal-auditor qualification criteria. Directs / Requires • Functions to identify accountable owners and provide records, evidence, responses, and remediation plans within defined timeframes., • Cross-functional review of significant quality-system, governance, handoff, or recurring process failures., • Temporary containment or escalation when a documented quality or compliance risk requires immediate management attention, subject to executive authority and applicable policy. Recommends • Quality and governance priorities, system investments, eQMS or workflow tools, resources, external support, and policy changes., • Process redesign and continuous-improvement initiatives based on risk, recurrence, business impact, and measurable benefit. ANCILLARY RESPONSIBILITIES· • All other dutiesas required or needed. PREFERRED QUALIFICATIONS: • ISO 9001 Lead Auditor, ASQ CQA, CMQ/OE, CQE, Lean Six Sigma, CIA, or comparable certification., • Working awareness of FDA, CE, UL, IEC, EMC, product-launch controls, and laser-safety requirements sufficient to identify the correct specialist, approval, evidence, and escalation path. Specialist expertise is not required., • Experience in scientific instrumentation, medical technology, precision capital equipment, or another regulated or quality-intensive industry. KNOWLEDGE, SKILLS & ABILITIES: • Bachelor’s degree in quality, engineering, science, business, regulatory affairs, operations, or a related field; equivalent relevant experience may be considered., • Experience implementing or significantly improving an eQMS, document-control, workflow, dashboard, or enterprise action-tracking platform, • Substantial progressive experience in quality management systems, quality assurance, audits, CAPA, controlled documentation, or management-system improvement., • Demonstrated business experience redesigning processes and leading cross-functional improvement in a complex organization., • Demonstrated ability to plan audits, evaluate evidence, document findings, manage responses, and verify closure., • Experience with process governance, internal controls, enterprise risk, policy governance, or cross-functional remediation, • Strong process-thinking and documentation discipline: ability to define owners, steps, decisions, controls, records, evidence, and escalation paths., • Strong written and verbal communication, neutral facilitation, sound judgment, and ability to influence senior leaders across functions., • Ability to handle sensitive audit, personnel, customer, supplier, and management information with appropriate confidentiality., • Working knowledge of Microsoft 365 and document/workflow platforms such as SharePoint or an equivalent system.
