Quality Assurance Specialist

Quality Systems & Compliance

• Maintain and support the organization’s Quality Management System (QMS) in accordance with applicable standards (e.g., ISO 9001, ISO 13485, ISO 14001,etc).
• Ensure quality policies, procedures, and work instructions remain up to date and compliant.
• Prepare and maintain quality documentation, logs, reports, and audit records. Audit Support & Execution
• Participate in internal audits and support external audits with certification bodies, customers, or regulatory authorities.
• Assist in audit preparation activities, evidence gathering, and follow-up actions.
• Monitor audit findings and coordinate corrective and preventive action activities (CAPA). Corrective & Preventive Action (CAPA) Management
• Investigate quality issues and non-conformities to determine root cause.
• Develop and track corrective and preventive action plans to ensure timely closure.
• Verify the effectiveness of implemented actions. Process & Quality Control
• Support process owners in maintaining consistent quality controls across workflows.
• Review and analyze quality data to identify trends or improvement opportunities.
• Conduct quality inspections, sampling, or verification activities as required. Continuous Improvement •Assist the Process Automation Specialist with identifying opportunities to optimize processes, reduce defects, and strengthen compliance.
• Collaborate with cross-functional teams to drive quality improvements. Supplier & Calibration Support
• Maintain calibration records and ensure equipment used for inspection and testing is up to standard. We are an Equal Opportunity/Affirmative Action Employer.