Key Responsibilities

1. QMS Strategy, Governance & Compliance

·    Define and lead the site QMS strategy, priorities, and improvement roadmap.

·    Ensure alignment with corporate, global, regulatory, and customer requirements.

·    Oversee QMS processes, including document control, change management, training, risk management, and process governance.

·    Drive standardization and effective deployment of QMS requirements across functions.

·    Advise site leadership on QMS performance, compliance risks, and improvement priorities.

2. Audit Leadership

·    Lead the strategy and readiness for internal, external, certification, corporate, and customer audits.

·    Oversee audit planning, auditor capability, evidence quality, audit responses, and closure of findings.

·    Represent the organization during significant audits and management discussions.

·    Drive systemic improvement based on audit trends and lessons learned.

·    Promote a zero non-conformance mindset and sustained audit readiness.

3. Non-Conformance & CAPA Management

·    Provide governance for non-conformance, root cause analysis, corrective action, and effectiveness verification.

·    Ensure significant and recurring issues are properly escalated, investigated, and resolved.

·    Drive systemic corrective actions to prevent recurrence across processes and functions.

4. Performance Monitoring & Management Review

·    Define and monitor QMS KPIs, including audit performance, CAPA effectiveness, process compliance, and system health.

·    Lead management reviews and business process reviews using the PDCA approach.

·    Provide data-driven insights, dashboards, and recommendations to senior leadership.

·    Ensure actions and decisions from management reviews are effectively followed through.

5. Continuous Improvement & Digital Transformation

·    Lead quality-system improvement initiatives and cross-functional transformation projects.

·    Drive digitalization, automation, analytics, and AI solutions to improve QMS efficiency and visibility.

·    Simplify and standardize processes while maintaining effective controls and compliance.

·    Promote a culture of continuous improvement and operational excellence.

6. Risk Management

·    Lead QMS risk identification, assessment, mitigation, monitoring, and escalation.

·    Ensure alignment with enterprise risk-management and business continuity frameworks.

·    Oversee quality risks related to changes, suppliers, new products, technologies, and operations.

·    Communicate significant risks and mitigation status to leadership.

7. Stakeholder & Cross-Functional Alignment

·    Partner with manufacturing, engineering, operations, quality, and support functions.

·    Align site practices with global QMS standards and strategic priorities.

·    Engage customers, auditors, certification bodies, suppliers, and other external stakeholders when required.

·    Influence leadership and stakeholders on quality strategies, priorities, and risk-based decisions.

8. People Leadership & Capability Development

·    Lead, coach, and develop QMS managers, engineers, specialists, auditors, and process owners.

·    Build QMS capability, succession plans, and a sustainable talent pipeline.

·    Ensure QMS training and competency requirements are defined and fulfilled.

·    Promote accountability, collaboration, inclusion, and quality ownership across the organization.

Qualifications & Requirements

·    Bachelor’s or Master’s degree in Engineering, Science, Quality, Manufacturing, or a related field.

·    Typically 12 or more years of experience in Quality, QMS, Engineering, or Manufacturing, including leadership experience.

·    Strong knowledge of ISO 9001, IATF 16949, audit processes, CAPA, risk management, and management review.

·    Proven experience leading major audits, QMS governance, and cross-functional improvement programs.

·    Strong strategic thinking, analytical, problem-solving, and decision-making skills.

·    Proven people leadership, coaching, stakeholder management, and influencing capabilities.

·    Excellent communication and ability to engage senior leadership, customers, and global teams.

·    Artificial Intelligence (AI) proficiency is required.