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._