Strategic role responsible for architecting and maintaining a unified, Quality Management System framework. Report directly to the VP Global Quality. Define and harmonize relationship between Global and Regional procedures to increase QMS scalability in support global expansion.
Core Responsibilities:
Strategic Global QMS Governance & Architecture
- Define QMS Structure: Architect a unified quality management framework that distinguishes between high-level global standards and regional/site-level execution.
- Global Harmonization: Lead the development and harmonization of key Global QMS processes to ensure alignment across diverse geographical sites.
- Strategy Development: Establish and maintain the overarching Global QMS strategy, policies, and standards in collaboration with senior leadership.
- System Maintenance: Oversee the implementation and maintenance of quality policies, and management review structures.
Quality Assurance & Compliance Management
- Regulatory Standards: Ensure the QMS meets all requirements for ISO 9001.
- Global Metrics & Monitoring: Establish and monitor meaningful quality metrics (KPIs) to assess QMS performance and report effectiveness.
- Change Leadership: Serve as a change leader, promoting a culture of quality, accountability, and continuous improvement throughout the organization.
Advanced Problem Solving & CAPA
- CAPA & 8D Leadership: Lead complex root cause analysis and manage the CAPA system using structured methodologies to drive permanent resolution of quality and reliability issues.
- Continuous Improvement: Partner with cross-functional stakeholders to identify improvement opportunities and implement strategies that deliver measurable results.
- Escalation Management: Ensure timely escalation and resolution of critical quality or compliance concerns to senior management.
Requirements:
- BS or advanced degrees in Engineering, Physical Sciences, or a related discipline.
- Minimum of five years of experience in quality systems, risk management, or regulatory compliance within a regulated manufacturing environment.
- Proven experience in global and regional QMS initiatives.
- ISO Expertise: Deep expertise in ISO 9001 is required. Experience with Medical Device Standards ISO 13485 or FDA 21 CFR 820, or DOD standards like AS9100 is a plus.
- Demonstrated CAPA systems and formal problem-solving methodologies.
- Practical knowledge of risk assessment and management standards such as ISO 14971.
- Background Manufacturing Execution Systems and statistical analysis tools are pluses.
- Collaboration: Strong interpersonal skills to work independently and collaborate in a geographically separated, multi-national and multi-functional team environment.
- Ability to effectively translate complex quality requirements into practical directions.