Quality Systems Specialist II

The Quality Systems Specialist II independently conducts complaint investigations, return material evaluations, root cause analysis activities, and corrective and preventive action processes to support the effectiveness of the Quality Management System.

This role serves as a primary investigator for routine to moderately complex quality issues and works cross-functionally to identify root causes, evaluate risk, implement corrective actions, and improve organizational performance.

The Quality Systems Specialist II applies risk-based decision making and structured problem-solving methodologies to ensure quality issues are effectively addressed and opportunities for improvement are identified.

Essential Responsibilities

Complaint, Investigation & CAPA Management


* Lead complaint evaluations and investigations.


* Conduct return material evaluations and associated investigations.


* Facilitate root cause analysis activities.


* Develop corrective and preventive action recommendations.


* Evaluate investigation effectiveness and closure readiness.


* Ensure investigations are timely, thorough, evidence-based, and compliant.

Risk Assessment & Decision Support


* Perform risk assessments associated with complaints, investigations, and quality issues.


* Support stakeholders in evaluating quality-related risks.


* Facilitate balanced decision-making based on available evidence.


* Escalate significant issues appropriately.

Trend Analysis & Continuous Improvement


* Analyze complaint, investigation, and CAPA data for emerging trends.


* Identify systemic issues requiring additional investigation or action.


* Recommend process improvements based on quality system performance.


* Support management system effectiveness initiatives.

 Cross-Functional Leadership


* Coordinate investigations involving multiple departments.


* Facilitate investigation meetings and action planning activities.


* Partner with Engineering, Manufacturing, Regulatory Affairs, Customer Care, and other stakeholders.


* Serve as a resource regarding investigation methodologies and quality system processes.

Coaching & Mentorship


* Provide guidance to Quality Systems Specialist I personnel.


* Support development of investigation and problem-solving skills within the organization.


* Share best practices and lessons learned.

Knowledge, Skills & Abilities

Required


* Strong understanding of complaint handling and investigation processes.


* Strong root cause analysis and problem-solving skills.


* Ability to independently manage multiple investigations.


* Strong analytical and decision-making capabilities.


* Effective facilitation and communication skills.


* Ability to influence stakeholders without direct authority.

Preferred


* Experience with risk management methodologies.


* Experience facilitating cross-functional investigations.


* Experience i...