Quality Systems & Change Management Leader

CQ Medical; Pennsylvania; On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental, and Vision coverage

Free life insurance, short and long‑t­

401(k) matching with immediate vesting

Generous PTO and 11 paid holidays

Job summary

CQ Medical is seeking a Manager, Quality Systems & Change Management to lead the QMS governance, change management, and risk-based process improvements across the enterprise.

This role works cross-functionally with Engineering, Manufacturing, Regulatory Affairs, Compliance, Product Line Management, Supply Chain, and Customer Care to ensure quality, compliance, and business growth while simplifying processes and avoiding unnecessary burden.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, Business, or related discipline; or equivalent combination of education and experience.
• 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.
• Lead complaint handling, CAPA, investigations, and risk-based actions.
• Oversee change management and configuration governance across products and processes.
• Promote risk-based thinking and governance to reduce unnecessary controls.
• Develop organizational capability and coach Quality Systems staff.

Skills

QMS knowledge

Change management

Root cause analysis

Risk management

Leadership

Stakeholder management

Communication skills

Education

Bachelor's degree in a related field

Tools

ERP systems

PLM systems

QMS software

LMS

Job description

CQ Medical is seeking a Manager, Quality Systems & Change Management to lead the QMS governance, change management, and risk-based process improvements across the enterprise.

This role works cross-functionally with Engineering, Manufacturing, Regulatory Affairs, Compliance, Product Line Management, Supply Chain, and Customer Care to ensure quality, compliance, and business growth while simplifying processes and avoiding unnecessary burden.