Global QMS Manager - Marlborough, MA
IPG Photonics, Marlborough, MA, United States
Overview
The Global QMS Manager at IPG Photonics is responsible for architecting and maintaining a unified, world‑class Quality Management System (QMS) framework. Reporting to the VP of Global Quality, the role defines the relationship between Tier 1 (Global) standards and Tier 2 (Regional) procedures to ensure seamless compliance and operational excellence. It focuses on increasing QMS scalability to support rapid global expansion and evolving manufacturing footprints.
Responsibilities
Architect a unified QMS framework that differentiates between global standards and regional execution.
Lead the development and harmonization of critical global QMS processes for alignment across sites.
Establish and maintain the overarching Global QMS strategy, policies, and standards with senior leadership.
Oversee system implementation, maintenance of quality policies and management review structures.
Ensure QMS meets ISO 9001 requirements.
Establish and monitor quality metrics (KPIs) to assess QMS performance.
Serve as a change leader to promote a culture of quality, accountability, and continuous improvement.
Lead complex root‑cause analysis, CAPA, and 8D methodologies to resolve quality and reliability issues.
Partner with cross‑functional stakeholders for continuous improvement and measurable outcomes.
Escalate and resolve critical quality or compliance concerns to senior management.
Qualifications
Bachelor's degree in Engineering, Physical Sciences or related discipline; advanced degree a plus.
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.
Deep expertise in ISO 9001; experience with ISO 13485, FDA 21 CFR 820, or AS9100 is highly preferred.
Demonstrated experience with CAPA systems and formal problem‑solving methodologies.
Knowledge of risk assessment standards such as ISO 14971.
Experience with MES and statistical tools like Minitab (plus).
Strong interpersonal and communication skills for geographically separated, multi‑national teams.
Location
377 Simarano Drive, Marlborough, Massachusetts 01752, United States
Employment Type
Exempt
Compensation
MA: $112,436–$148,978
Benefits
Paid vacation time accrued by years of service.
Paid sick time.
12 paid holidays each calendar year.
Medical, dental, and vision insurance; options for HSA/FSA.
Dependent Care FSA.
Paid basic life and AD&D insurance.
Short‑term and long‑term disability insurance.
401(k) plan with company matching.
Employee Stock Purchase Plan (ESPP).
Tuition reimbursement program.
Employee Assistance Program (EAP).
Adoption assistance.
Pet insurance.
Parental bonding leave.
Bright Horizons backup care and college coaching.
#J-18808-Ljbffr
The Global QMS Manager at IPG Photonics is responsible for architecting and maintaining a unified, world‑class Quality Management System (QMS) framework. Reporting to the VP of Global Quality, the role defines the relationship between Tier 1 (Global) standards and Tier 2 (Regional) procedures to ensure seamless compliance and operational excellence. It focuses on increasing QMS scalability to support rapid global expansion and evolving manufacturing footprints.
Responsibilities
Architect a unified QMS framework that differentiates between global standards and regional execution.
Lead the development and harmonization of critical global QMS processes for alignment across sites.
Establish and maintain the overarching Global QMS strategy, policies, and standards with senior leadership.
Oversee system implementation, maintenance of quality policies and management review structures.
Ensure QMS meets ISO 9001 requirements.
Establish and monitor quality metrics (KPIs) to assess QMS performance.
Serve as a change leader to promote a culture of quality, accountability, and continuous improvement.
Lead complex root‑cause analysis, CAPA, and 8D methodologies to resolve quality and reliability issues.
Partner with cross‑functional stakeholders for continuous improvement and measurable outcomes.
Escalate and resolve critical quality or compliance concerns to senior management.
Qualifications
Bachelor's degree in Engineering, Physical Sciences or related discipline; advanced degree a plus.
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.
Deep expertise in ISO 9001; experience with ISO 13485, FDA 21 CFR 820, or AS9100 is highly preferred.
Demonstrated experience with CAPA systems and formal problem‑solving methodologies.
Knowledge of risk assessment standards such as ISO 14971.
Experience with MES and statistical tools like Minitab (plus).
Strong interpersonal and communication skills for geographically separated, multi‑national teams.
Location
377 Simarano Drive, Marlborough, Massachusetts 01752, United States
Employment Type
Exempt
Compensation
MA: $112,436–$148,978
Benefits
Paid vacation time accrued by years of service.
Paid sick time.
12 paid holidays each calendar year.
Medical, dental, and vision insurance; options for HSA/FSA.
Dependent Care FSA.
Paid basic life and AD&D insurance.
Short‑term and long‑term disability insurance.
401(k) plan with company matching.
Employee Stock Purchase Plan (ESPP).
Tuition reimbursement program.
Employee Assistance Program (EAP).
Adoption assistance.
Pet insurance.
Parental bonding leave.
Bright Horizons backup care and college coaching.
#J-18808-Ljbffr