Manager, Quality Systems & Change Management

CQ Medical•New Garden Township, PA

4d•Onsite

About The Position

The Manager, Quality Systems & Change Management is responsible for the development, governance, effectiveness, and continuous improvement of the Quality Management System (QMS) and associated Change Management processes. This role serves as the organizational owner of the management system and is responsible for ensuring business processes remain effective, scalable, risk-based, compliant, and aligned with organizational objectives. The Manager provides leadership for Quality Systems and Change Management activities, including management system governance, complaint management, return material evaluation, investigations, corrective and preventive actions, risk management, configuration management, product data governance, and change implementation. Working cross-functionally with Engineering, Manufacturing, Regulatory Affairs, Compliance, Product Line Management, Supply Chain, Customer Care, and other business functions, this role ensures the management system enables quality, compliance, operational effectiveness, and business growth without creating unnecessary complexity or administrative burden. Success in this position requires strong systems thinking, leadership, technical judgment, business acumen, and a commitment to developing both people and organizational capability.

Requirements

Strong understanding of Quality Management Systems and process-based management systems.
Strong understanding of complaint handling, investigations, root cause analysis, corrective action, and risk management methodologies.
Strong understanding of change management, configuration management, and process governance principles.
Ability to evaluate management system effectiveness and identify practical improvement opportunities.
Strong systems-thinking, analytical, and problem-solving skills.
Ability to influence stakeholders without direct authority.
Strong leadership, coaching, and talent development capabilities.
Excellent written and verbal communication skills.
Ability to balance quality, compliance, risk, efficiency, and business objectives.
Ability to challenge assumptions and drive objective decision making.
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.

Nice To Haves

Experience with ERP, PLM, QMS, LMS, and related business systems.
Experience supporting engineering, manufacturing, product development, or regulated business environments.
Experience facilitating risk assessments, investigations, management reviews, and cross-functional improvement initiatives.
Knowledge of configuration management, product structures, bills of material, and engineering change processes.
Medical device or other regulated industry experience.
ASQ certifications, Six Sigma certifications, or equivalent professional credentials.
Experience developing people, management systems, and organizational capability.

Responsibilities

Own and continuously improve the Quality Management System and associated governance processes.
Ensure management system processes remain effective, scalable, compliant, risk-based, and aligned with business objectives.
Monitor management system performance through quality metrics, process performance indicators, management reviews, audit outcomes, customer feedback, and improvement activities.
Assess management system effectiveness and identify opportunities to improve process capability, efficiency, consistency, and organizational performance.
Drive simplification, standardization, and optimization of business processes while maintaining appropriate controls.
Ensure appropriate integration and interaction between management system processes across the organization.
Support development and maintenance of procedures, work instructions, standards, and process documentation.
Provide leadership and oversight for complaint handling, return material evaluation, investigations, root cause analysis, corrective action, preventive action, and effectiveness verification processes.
Ensure quality issues are appropriately evaluated, investigated, resolved, and prevented from recurring.
Serve as the escalation resource for complex complaints, investigations, product issues, process issues, and systemic quality concerns.
Lead or support investigations requiring advanced technical judgment and cross-functional coordination.
Facilitate effective root cause analysis and evidence-based problem solving.
Ensure corrective and preventive actions address true systemic causes and drive sustainable improvement.
Promote organizational learning through effective investigation and knowledge-sharing practices.
Provide leadership and oversight for configuration management, product data governance, and change implementation activities.
Ensure product, process, documentation, training, ERP, software, and business system changes are appropriately assessed, coordinated, implemented, and verified.
Establish and maintain effective change management processes that balance control, compliance, and business agility.
Support successful execution of engineering, manufacturing, quality system, regulatory, and business process changes.
Ensure organizational adherence to established change management and configuration control requirements.
Promote consistency, discipline, and accountability in change execution across the enterprise.
Promote adoption of risk-based thinking throughout the organization.
Support leaders and process owners in identifying, assessing, mitigating, and monitoring risk.
Facilitate practical decision-making that appropriately balances quality, compliance, operational effectiveness, and business objectives.
Evaluate the effectiveness of controls and governance mechanisms used to manage organizational risk.
Challenge unnecessary controls, excessive documentation, and activities that do not meaningfully reduce risk or improve outcomes.
Support development of risk management capabilities throughout the organization.
Recruit, develop, coach, and evaluate Quality Systems Specialists and Configuration & Change Management Specialists.
Build organizational capability in investigation methodologies, root cause analysis, risk assessment, problem solving, process management, and change management.
Foster a culture of accountability, professionalism, continuous learning, and ownership.
Reduce organizational dependency on individuals through cross-training, documentation, succession planning, and knowledge transfer.
Partner with Engineering, Manufacturing, Regulatory Affairs, Compliance, Product Line Management, Supply Chain, Customer Care, and other functions to improve management system effectiveness and business performance.
Serve as a trusted advisor regarding quality systems, investigations, risk management, process governance, and change management.
Promote collaboration and alignment across organizational boundaries.
Identify and lead initiatives that improve quality system effectiveness, process performance, change execution, and organizational capability.
Develop and maintain meaningful performance indicators to measure management system and change management effectiveness.
Monitor trends and recommend actions to improve organizational performance.