Lead ISO 9001 Internal Auditor

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Take full ownership and lead the internal auditing program for the Quality Management System (QMS).

• Develop, implement, and manage the annual internal audit calendar that encompasses relevant ISO 9001 clauses and operational processes.

• Conduct focused, risk-oriented internal audits throughout departmental workflows and established standard operating procedures.

• Create audit plans, checklists, working documents, and formal Non-Conformance Reports (NCRs).

• Assess organizational processes in relation to ISO 9001 standards, risk-based considerations, the Context of the Organization, and leadership involvement.

• Analyze root cause investigations and review proposed Corrective and Preventive Action (CAPA) plans.

• Monitor, confirm, and finalize corrective action plans prior to external registrar audits.

• Execute periodic risk-based quality audits of essential suppliers, vendors, and critical subcontractors.

• Generate audit trend analyses, QMS metrics, and risk assessments for executive ISO 9001 Management Review meetings.

• Prepare the organization and the QA department for ISO 9001 registrar certification, recertification, and surveillance audits.

• Act as the technical liaison and host during external ISO 9001 registrar audits.

• Carry out additional QMS audit and compliance responsibilities as assigned.

⛳️ Requirements

• At least 10 years of auditing experience.

• Over a decade of direct experience in leading ISO 9001 internal or external quality assurance audits.

• ISO 9001 Lead Auditor Certification (IRCA, Exemplar Global, or equivalent) is required.

• Bachelor's Degree in Quality Management, Engineering, Business Administration, or a related technical discipline.

• Demonstrated success in independently designing, establishing, and managing a comprehensive ISO 9001 QMS audit program with full autonomy.

• Advanced knowledge of ISO 9001 standard requirements, Annex SL structure, and process-oriented auditing methodologies.

• Strong experience in tracking non-conformances, root cause analysis techniques (5 Whys, Fishbone), and verifying CAPA effectiveness.

• Capability to work independently, prioritize tasks, and meet program objectives within an 8-hour weekly commitment.

• Excellent written and presentation skills to effectively communicate audit findings to process owners and executive management.

• Authorization to work for any employer in the United States.

• Additional certifications such as ASQ Certified Quality Auditor (CQA) or Certified Internal Auditor (CIA) are preferred.

• Experience in facilitating and managing successful ISO 9001 registrar certification and surveillance audits.

• Practical and pragmatic approach to compliance, balancing strict ISO 9001 adherence with operational efficiency.

• Multi-industry auditing experience across manufacturing, engineering, software, or technology sectors.

🏝️ Benefits

• Competitive part-time hourly pay.

• Flexible working arrangement (e.g., one full day per week or split across two half-days).

• Option for hybrid or remote work flexibility, depending on audit schedule requirements.

• Opportunity to influence quality strategy and drive continuous improvement in a significant ownership role.