Job Description
Job Description Quality Assurance Assistant Reports To: Quality Supervisor and/or Quality Manager Pay: $18/hrPosition Overview The Quality Assurance Assistant supports the organization’s Quality Management System and helps ensure that all distributed medical devices meet established quality standards and applicable regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820. This position works closely with Operations, Engineering, Customer Service, Production, and Warehouse teams to maintain regulatory compliance, resolve quality concerns, and support continued product quality. Key ResponsibilitiesQuality Management System Support
- Assist the Quality Supervisor and Quality Manager with establishing, maintaining, and improving an effective Quality Management System.
- Support compliance with ISO 13485, FDA Quality System Regulation requirements, and other applicable medical-device standards.
- Help develop and implement quality assurance processes, inspection methods, product-testing protocols, and quality standards.
- Perform facility process audits to verify compliance with QMS requirements and documented procedures.
Documentation and Reporting
- Maintain accurate records of inspection results, quality-control data, test reports, nonconformances, and corrective actions.
- Prepare reports summarizing quality trends, nonconformance issues, and opportunities for improvement.
- Ensure quality documentation is complete, accurate, properly maintained, and readily available for review.
Corrective and Preventive Actions
- Investigate quality issues and nonconformances to help identify root causes.
- Work with the appropriate departments to develop and implement corrective and preventive actions.
- Monitor the effectiveness of corrective actions and support continuous-improvement initiatives.
- Coordinate the return process for nonconforming materials identified in Production or the Warehouse.
Audits and Regulatory Compliance
- Coordinate and participate in internal and external audits.
- Remain current on ISO 13485, FDA requirements, and other applicable medical-device regulations.
- Help ensure that quality-control activities comply with organizational procedures and regulatory standards.
Training and Cross-Functional Support
- Assist with developing and delivering employee training related to quality standards and procedures.
- Collaborate with cross-functional teams to identify and reduce risks associated with the design, manufacture, and distribution of medical devices.
- Support the Quality Supervisor with investigating and resolving customer complaints involving product quality or service delivery.
- Perform additional duties as assigned by the Quality Supervisor or Quality Manager.
Preferred Qualifications
- Previous experience in quality assurance, quality control, medical-device manufacturing, or another regulated environment.
- Familiarity with ISO 13485, FDA 21 CFR Part 820, Quality Management Systems, and Good Documentation Practices.
- Experience with inspections, audits, nonconformance documentation, root-cause investigations, or CAPA processes is preferred.
- Strong attention to detail and organizational skills.
- Effective written and verbal communication skills.
- Ability to maintain accurate records and manage confidential information.
- Ability to collaborate effectively with multiple departments.
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