Quality Systems Specialist II

CQ Medical; Pennsylvania; On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Free life insurance

Disability insurance

Telehealth services

401(k) matching

Paid holidays

Job summary

CQ Medical is seeking a Quality Systems Specialist II to independently drive complaint investigations, CAPA activities, and risk assessments across cross‑functional teams. You will identify root causes, implement corrective actions, and improve the Quality Management System to ensure compliance and product quality.

The role emphasizes structured problem‑solving, timely investigations, and leadership in coaching junior personnel while partnering with Engineering, Manufacturing, Regulatory

Qualifications

• Bachelor's degree or equivalent experience in Quality, Engineering, Manufacturing, Life Sciences, Business, or related discipline.
• Minimum 3 years of relevant experience in quality, investigations, or CAPA.
• ASQ certification or equivalent credentials 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 related to complaints and CAPA.
• Support stakeholders in evaluating quality risks and enable balanced decisions.
• Analyze data for trends and drive continuous improvement.
• Coordinate cross‑functional investigations and mentor junior staff.

Skills

Complaint handling

Root cause analysis

Investigation management

Analytical thinking

Decision making

Facilitation & communication

Stakeholder influence

Education

Bachelor's degree or equivalent experience (Quality, Engineering, Life Sciences, Business)

Minimum 3 years relevant experience

ASQ certification (Preferred)

Tools

Quality Management System

Job description

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.

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

• 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 in medical device or regulated industries.

Education & Experience

• Bachelor's degree or equivalent experience in Quality, Engineering, Manufacturing, Life Sciences, Business, or related discipline.
• Minimum 3 years of relevant experience.

Preferred

• ASQ certification or equivalent professional credentials.
• Medical device or other regulated industry experience.

Benefits

Medical, Dental, and Vision coverage starts on Day One!

Free life insurance, short and long‑term disability insurance, Telehealth appointments, and Employee Assistance Program.

Immediate vesting of 401(k) matching.

Generous PTO and 11 paid holidays a year.

And, most importantly, truly meaningful work! Would you like to make a difference in the lives of cancer patients and their families? We design and manufacture radiation oncology medical devices to ensure more accurate, comfortable treatment for cancer patients. CQ Medical is the global market leader in patient positioning. As an innovative medical device company, we focus on discovering, developing, and distributing technology‑driven solutions to improve outcomes for radiotherapy patient positioning.

Join us and earn a Paycheck with a Purpose. www.cqmedical.com