Summary

The Quality Management System (QMS) Auditor is responsible for the systematic evaluation, maintenance, and continuous improvement of the organization's overall Quality Management System. Rather than inspecting individual physical parts, this role focuses on auditing the processes, policies, and systems that govern production, engineering, supply chain, and customer service.

The successful candidate ensures total alignment with ISO 9001:2015 (and other industry-specific standards), manages the internal audit schedule, mitigates operational risk, and acts as the primary liaison during formal external and third-party registrar audits.

Detailed Description

Performs tasks such as, but not limited to, the following:

1. QMS & Process Governance

Internal Audit Management: Develop, schedule, and execute the annual Internal QMS Audit Plan across all departments (Engineering, Operations, Supply Chain, HR, and Sales) to verify process effectiveness and ISO 9001:2015 compliance.
Process Approach Auditing: Audit organizational workflows from end to end, ensuring that process inputs, outputs, and performance metrics (KPIs) are clearly defined and controlled.
External Audit Liaison: Serve as the key point of contact and facilitator for third-party registrar audits, customer quality audits, and regulatory body inspections.

2. CAPA & Continuous Improvement

Corrective & Preventive Actions (CAPA): Issue and track Non-Conformance Reports (NCRs) resulting from system audits. Partner with process owners to ensure thorough Root Cause Analysis (using 5-Why, 8D, or Fishbone diagrams).
Effectiveness Verifications: Perform follow-up audits to rigorously verify that implemented corrective actions have permanently resolved the systemic issues and prevent recurrence.
Risk-Based Thinking: Evaluate company processes for operational risks and opportunities, ensuring risk mitigation steps are integrated directly into the QMS.

3. Documentation & Document Control

Controlled Document Review: Audit the document control system to ensure all standard operating procedures (SOPs), work instructions, and quality manuals are up-to-date, approved, and accessible.
Management Review Support: Gather, analyze, and present audit trend data, non-conformance metrics, and customer satisfaction indicators to senior leadership during scheduled Management Review meetings.

4. Training & Quality Culture

ISO Awareness: Conduct training sessions for plant personnel and management regarding ISO 9001 requirements, internal audit processes, and the importance of compliance.
Auditor Mentorship: Train and mentor a team of cross-functional internal auditor volunteers to assist with departmental reviews.

Knowledge/Skills/Competencies

Education

Bachelor's degree in Business Administration, Engineering, Quality Management, or a related technical field (or equivalent extensive experience).

Experience

3-5 years of dedicated experience working within an ISO 9001 certified environment, with a primary focus on quality system auditing or compliance management.
Proven experience leading full-lifecycle internal audits and managing a corporate CAPA system.

Required & Preferred Certifications

- Required: ISO 9001:2015 Internal Auditor certification (Lead Auditor certification highly preferred).
- Preferred: ASQ Certified Quality Auditor (CQA) or Certified Manager of Quality/Organizational Excellence (CMQ/OE).

Technical Requirements & Skills

ISO Standards	Mastery of ISO 9001:2015 clauses, definitions, and high-level structure (Annex SL).
Audit Methodologies	Expert proficiency in audit planning, interviewing techniques, evidence collection, and report writing (ISO 19011 standards).
Core Quality Tools	Deep understanding of Root Cause Analysis tools (8D, Fishbone, 5-Why) and Risk Management (FMEA).
Data & Systems	Experience navigating Quality Management Software (e.g., ETQ, MasterControl, TrackWise) and ERP systems (SAP/Oracle).
Analytical Skills	Ability to analyze complex procedural data to identify trends, gaps, and systemic vulnerabilities.

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.

QMS Auditor / Operations Quality Specialist