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.
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