Quality Systems Investigator II – CAPA & Root Cause

Cqmedical; Pennsylvania; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, and Vision coverage

Life insurance

Short and long-term disability

Telehealth

Employee Assistance Program

401(k) matching

Paid time off and holidays

Job summary

CQ Medical is seeking a Quality Systems Specialist II to independently lead complaint investigations, return material evaluations, and CAPA activities within a robust Quality Management System.

The role requires strong root cause analysis, risk assessment, and cross-functional collaboration with Engineering, Manufacturing, Regulatory Affairs, and Customer Care to drive effective corrective actions and prevent recurrence.

Qualifications

• Bachelor's degree or equivalent in Quality, Engineering, Manufacturing, Life Sciences, Business, or related discipline.
• Minimum 3 years of relevant experience.
• Strong understanding of complaint handling and investigation processes.
• Strong root cause analysis and problem-solving skills.
• Experience in medical device or regulated industries is preferred.
• ASQ certification or equivalent credentials is preferred.

Responsibilities

• 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.
• 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.
• Analyze complaint, investigation, and CAPA data for trends.
• Identify systemic issues requiring additional investigation or action.
• Recommend process improvements based on quality system performance.
• Support management system effectiveness initiatives.
• Coordinate investigations involving multiple departments.
• Facilitate investigation meetings and action planning.
• Partner with Engineering, Manufacturing, Regulatory Affairs, Customer Care, and other stakeholders.
• Serve as a resource regarding investigation methodologies and quality system processes.
• 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.

Skills

Complaint handling

Root cause analysis

Investigations management

Analytical thinking

Facilitation

Stakeholder influence

Education

Bachelor's degree in Quality/Engineering/Life Sciences

ASQ certification

Job description

CQ Medical is seeking a Quality Systems Specialist II to independently lead complaint investigations, return material evaluations, and CAPA activities within a robust Quality Management System.

The role requires strong root cause analysis, risk assessment, and cross-functional collaboration with Engineering, Manufacturing, Regulatory Affairs, and Customer Care to drive effective corrective actions and prevent recurrence.