Internal Auditor

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.

Job Duties

• 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 reqularly

• Prepare audit checklists and documentation based on applicable standards, regulartory 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

• To reach clear and unambiguous conclusions based on audit observations and to remain true to the conclusions

• Being 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

• To conduct audits for Verification of Effectiveness on CAPA's

• Understand and apply all sections of AS9100, ISO9001 and ISO13485

Qualifications

Education: Atleast high school graduate. Previous audit experience preferred

Knowledge: 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.
Experience: Previous audit experience a plus as well as a strong interest in quality

Working Conditions:

Environment: Office Environment: Physical Requirements… 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, to walk short distances.