Global QMS Manager - Marlborough, MA

The Global QMS Manager at IPG Photonics is a strategic role responsible for architecting and maintaining a unified, world-class Quality Management System (QMS) framework. Reporting directly to the VP of Global Quality, this individual defines the relationship between Tier 1 (Global) standards and Tier 2 (Regional) procedures to ensure seamless compliance and operational excellence. A primary focus is to increase QMS scalability, creating a robust infrastructure that supports rapid global expansion and evolving manufacturing footprints. By harmonizing these systems, this role ensures high-level quality standards are consistently and efficiently applied across all global sites.

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 Corrective and Preventive Action (CAPA) system using structured methodologies like 8D 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.

* Education: Bachelor's degree in Engineering, Physical Sciences, or a related discipline. Advanced degree (Master's or Ph.D.) in a related technical field is a plus.

* Experience: Minimum of 5-10 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. Medical Device Standards: Experience with ISO 13485 or FDA 21 CFR 820 is highly preferred. Defense Standards: Experience with defense-related standards like AS9100 is a plus.

* Demonstrated experience with CAPA systems, and formal problem-solving methodologies.

* Risk Management (plus) : Practical knowledge of risk assessment standards such as ISO 14971.

* Advanced Tools (plus): Experience with Manufacturing Execution Systems (MES) and statistical analysis tools like Minitab.

* Collaboration: Strong interpersonal skills to work independently in a geographically separated, multi-national and multi-functional team environment.

* Communication: Ability to effectively translate complex quality requirements into practical directions for the organization.