QMS Auditor | ISO/AS9100 & CAPA Specialist

Total Plastic Solutions; Lynchburg (VA); On-site; USD 65,000 - 90,000; Full time

Job summary

Total Plastic Solutions is seeking an Internal Auditor to assess conformance with AS9100, ISO9001 and ISO13485 and drive continuous improvement of the QMS in our Lynchburg, VA facility.

You will plan and perform internal audits, develop checklists, document findings and oversee CAPAs. Collaboration with cross-functional teams and support for external audits are essential to ensure regulatory compliance and product quality.

Qualifications

• High school graduate required.
• Previous audit experience preferred.
• Strong communication and documentation skills.
• Detail oriented with good listening and analytical abilities.
• Understanding of AS9100, ISO9001 and ISO13485 a plus.

Responsibilities

• Plan, schedule and conduct internal audits in accordance with AS9100, ISO9001 and ISO 13485 requirements.
• Develop and maintain an internal audit schedule to ensure all areas of the QMS are audited regularly.
• Prepare audit checklists and documentation based on applicable standards, regulatory requirements and company procedures.
• Conduct thorough audits, including interviews, document reviews and process observations.
• Document audit findings, nonconformities and opportunities for improvement in detailed audit reports.
• Communicate audit results to relevant stakeholders and follow up on corrective actions.
• Assist in coordinating the CAPA process, including identification, documentation and investigation of nonconformities.
• Collaborate with cross-functional teams to perform root cause analysis and develop effective corrective and preventive actions.
• Monitor the implementation and effectiveness of CAPAs to ensure timely resolution of issues.
• Maintain CAPA records and ensure compliance with regulatory and company requirements.
• Provide training and guidance to staff on CAPA processes and best practices.
• Participate in management reviews and provide input on QMS performance and improvement opportunities.
• Assist in preparing for external audits and regulatory inspections.
• To conduct audits for Verification of Effectiveness on CAPA's.
• Understand and apply all sections of AS9100, ISO9001 and ISO13485.

Skills

Communication

Detail orientation

Active listening

Quality standards

Education

High school diploma

Job description

Total Plastic Solutions is seeking an Internal Auditor to assess conformance with AS9100, ISO9001 and ISO13485 and drive continuous improvement of the QMS in our Lynchburg, VA facility.

You will plan and perform internal audits, develop checklists, document findings and oversee CAPAs. Collaboration with cross-functional teams and support for external audits are essential to ensure regulatory compliance and product quality.