Audit Program Management & Planning
Develop and maintain the annual internal audit schedule using a risk-based approach that considers process performance, customer concerns, quality metrics, organizational changes, and previous audit results.
Plan and coordinate system, process, layered, and compliance audits across all business functions and manufacturing operations.
Ensure audit coverage aligns with ISO 9001, customer-specific requirements, internal procedures, and regulatory obligations.
Support management review activities by providing audit performance summaries, trends, risks, and improvement opportunities.
Audit Execution & Compliance Verification
Conduct internal audits to evaluate compliance with documented procedures, work instructions, control plans, standards, and regulatory requirements.
Gather objective evidence through interviews, process observations, documentation reviews, and sampling of records.
Identify nonconformities, process gaps, risks, and opportunities for continual improvement using a fact-based and objective approach.
Document audit findings with clear supporting evidence and appropriate severity classifications.
Ensure audits assess both compliance and process effectiveness, focusing on customer impact and business risk.
Corrective Action & Continuous Improvement
Issue and manage nonconformance reports resulting from audit findings.
Partner with process owners to facilitate robust root cause analysis utilizing methodologies such as 5 Why, Fishbone, A3, and 8D.
Verify corrective and preventive actions are effectively implemented and sustained.
Conduct follow-up audits and effectiveness reviews to ensure closure of findings and prevent recurrence.
Identify systemic issues and recommend improvements to strengthen process capability and organizational performance.
QMS Governance & Documentation
Verify that documented information remains accurate, current, controlled, and aligned with operational practices.
Collaborate with Document Control to maintain procedures, policies, forms, records, and process documentation.
Evaluate compliance with change management processes to ensure new requirements, engineering changes, and process updates are properly implemented.
Monitor adherence to document control, record retention, training effectiveness, and competency requirements.
Data Analysis & Reporting
Track and analyze audit results, nonconformities, overdue actions, recurring findings, and process compliance trends.
Develop and maintain audit performance dashboards and key performance indicators.
Present audit findings, risk assessments, and improvement recommendations to management and cross-functional teams.
Utilize data analytics to identify emerging risks, process weaknesses, and opportunities for preventive action.
External Audit & Certification Support
Support external certification audits, customer audits, regulatory assessments, and surveillance audits.
Serve as a subject matter expert for ISO 9001 and applicable quality management requirements.
Coordinate audit logistics, evidence collection, and response preparation for external audits.
Assist functional teams in preparing corrective action responses and closure activities.
Training & Quality Culture
Train employees and process owners on QMS requirements, audit expectations, process compliance, and continuous improvement principles.
Develop and mentor internal auditors to ensure consistent audit execution and interpretation of standards.
Conduct auditor calibration sessions to ensure consistency in audit methodology and findings classification.
Promote a culture of quality, accountability, transparency, and continual improvement across the organization.