Head of Quality Systems & Change Management

Cqmedical; Pennsylvania; On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Generous PTO and paid holidays

Life insurance

Disability coverage

Employee Assistance Program

Job summary

CQ Medical in the United States (PA) seeks a Manager, Quality Systems & Change Management to lead the QMS governance, change management, and risk-based quality initiatives across engineering, manufacturing, regulatory, and product teams. This role drives continuous improvement, investigations, CAPA, data governance, and organizational capability while ensuring compliance and business growth.

The position emphasizes leadership, strategic thinking, and collaboration to optimize quality processes,

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, Business, or related discipline.
• Minimum 5 years of progressive experience in quality systems, engineering, manufacturing, quality, process improvement, change management, or related disciplines.
• Minimum 3 years of leadership, project leadership, or functional leadership experience.

Responsibilities

• Own and continuously improve the Quality Management System and governance processes.
• Monitor management system performance using quality metrics and audits.
• Lead investigations, root cause analyses, CAPA, and effectiveness verification.
• Provide oversight for change management, configuration management, and product data governance.
• Coach and develop Quality Systems Specialists and Change Management Specialists.
• Partner with cross-functional teams to improve quality system effectiveness and business performance.

Skills

Quality Systems

Change management

Root cause analysis

Risk management

Leadership

Communication

Systems thinking

Problem solving

Influence without authority

Education

Bachelor's degree in Engineering/Quality/Manufacturing/Life Sciences/Business

ASQ or Six Sigma certifications (preferred)

Tools

ERP

PLM

QMS

LMS

Job description

CQ Medical in the United States (PA) seeks a Manager, Quality Systems & Change Management to lead the QMS governance, change management, and risk-based quality initiatives across engineering, manufacturing, regulatory, and product teams. This role drives continuous improvement, investigations, CAPA, data governance, and organizational capability while ensuring compliance and business growth.

The position emphasizes leadership, strategic thinking, and collaboration to optimize quality processes,