Quality Improvement Specialist
- Audit Management
- Plan, schedule, and conduct routine and non-routine internal quality systems/process and THS-site audits.
- Assign and coordinate corrective actions and verify their effective implementation in response to audit findings.
- Support OPEX Director by maintaining and managing the internal audit schedule.
- Non-Conformance / CAPA Management:
- Lead investigations of incidents, issues, and trends. Leads / facilitates cross functional structured problem solving in support of investigations. Propose associated CAPA actions and prepare associated investigation reports.
- Manage and maintain the Corrective and Preventive Action (CAPA) process.
- Support other CAPA owners in the identification of root causes, implementation of corrective actions, and verification of effectiveness.
- Performs review/close out and effectiveness checks of completed CAPA, in accordance with the approved CAPA.
- Continuous Improvement:
- Proactively identify opportunities for process and quality improvements.
- Collaborate with cross-functional teams to implement enhancements to the QMS.
- Collect and analyze data to identify trends, root causes, and areas for improvement.
- After Action Reviews
- Lead After Action Reviews (AARs) to capture lessons learned and drive continuous improvement.
- Document findings and develop clear, actionable recommendations.
- Assign and track follow-up actions to ensure improvements are implemented.
- Maintain an accessible archive of AAR reports to support knowledge sharing.
- The above is not an exhaustive list of duties and other tasks may be assigned as necessitated by overall business objectives, as deemed reasonable and requested by the immediate supervisor, VP, or CEO.
- 1-3 years in a quality-focused role with a working knowledge of Quality Systems, Quality Tools, and root cause analysis
- Audit Experience (as auditee and/or auditor)
- Knowledge with EQMS
- Proficient in data analysis tools (Power BI, Excel, etc.)
- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
- Flexible and patient with changes
- Familiar with regulatory standards (e.g. ISO, OSHA)
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