Internal Auditor

Total Plastic Solutions•Lynchburg, VA

1d•Onsite

About The Position

Internal Auditors are responsible for conducting internal audits to ensure compliance with AS9001 and ISO13485 standards. This role involves evaluating the effectiveness of the Quality Management System (QMS), identifying areas for improvement and overseeing the Corrective and Preventive Actions (CAPA) process to ensure nonconformities are addressed effectively.

Requirements

At least high school graduate
Ability to communicate well with all roles within the organization
Detailed oriented
Good listener and communicator
Good understanding of the Internal Standards and the importance of a good quality management system
Good work ethic
Must be able to remain in a stationary position 80% of the time
Work is performed in an office environment and requires the ability to operate standard office equipment and keyboards
Must have the ability to lift and carry small parcels, packages and other items
Must have the ability to walk short distances

Nice To Haves

Previous audit experience preferred
Previous audit experience a plus
Strong interest in quality

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
Reach clear and unambiguous conclusions based on audit observations and remain true to the conclusions
Be fair and impartial to relevant personnel during the audit
Assist in the coordinating of the CAPA process, including the 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
Conduct audits for Verification of Effectiveness on CAPA's
Understand and apply all sections of AS9100, ISO9001 and ISO13485