Quality Systems Specialist II
About The Position
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.
Requirements
- 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.
- Bachelor's degree or equivalent experience in Quality, Engineering, Manufacturing, Life Sciences, Business, or related discipline.
- Minimum 3 years of relevant experience.
Nice To Haves
- Experience with risk management methodologies.
- Experience facilitating cross-functional investigations.
- Experience in medical device or regulated industries.
- ASQ certification or equivalent professional credentials.
- Medical device or other regulated industry experience.
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 emerging 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 activities.
- 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.
Benefits
- Medical coverage starts on Day One!
- Dental coverage starts on Day One!
- Vision coverage starts on Day One!
- Free life insurance
- Short-term disability insurance
- Long-term disability insurance
- Telehealth Appointments
- Employee Assistance Program
- Immediate vesting of 401(k) matching
- Generous PTO
- 11 Paid Holidays a year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
