Quality Assurance Specialist

The Quality Assurance Specialist is responsible for managing and maintaining the laboratory’s Quality Management System (QMS) in compliance with ISO/IEC 17025 (Testing/Calibration) and ISO/IEC 17065 (Product Certification). This role ensures that all testing, calibration, and certification activities meet regulatory, accreditation, and customer requirements. The Quality Assurance Specialist will lead internal audits, oversee corrective actions, manage document control, and serve as the primary liaison with accreditation bodies.JOB FUNCTIONSMaintain and continuously improve the QMS in compliance with ISO 17025 and ISO 17065.Ensure document control and proper recordkeeping for policies, procedures, and work instructions.Develop and monitor quality objectives and key performance indicators (KPIs).Serve as the primary contact for accreditation bodies and regulatory agencies.Ensure the lab meets all ISO/IEC 17025 and ISO/IEC 17065 accreditation requirements.Manage accreditation audits, external assessments, and regulatory inspections.Plan, execute, and document internal audits to assess compliance and identify risks.Investigate nonconformities, implement corrective actions, and verify effectiveness.Lead root cause analysis (RCA) and continuous improvement initiatives.Ensure personnel involved in testing and certification are qualified, trained, and competent.Maintain training records and competency assessments.Conduct or coordinate quality system training sessions.Identify, assess, and mitigate risks to testing validity and certification decisions.Promote continuous improvement initiatives in test methods, certification processes, and quality practices.Implement Failure Modes and Effects Analysis (FMEA) or similar methodologies where applicable.Address customer complaints and ensure proper investigation and resolution.Communicate quality system updates and compliance status to management.Work with technical staff to ensure test and certification results are accurate and reliable.