Senior Quality Assurance Analyst

Senior Quality Assurance Analyst

Location: Columbus, Indiana, United States

Industry: Motor Vehicle Manufacturing

Work Setting: Hybrid

The QMS Specialist serves as the primary subject matter expert for Quality Management Systems (QMS), calibration compliance, document control, records management, and audit programs. This role drives ISO 9001 compliance, risk-based thinking, corrective action management, and continuous improvement initiatives while partnering with plant leadership, department stakeholders, and external vendors to sustain world-class quality standards.

Key Responsibilities

Quality Management System (QMS) Leadership

• Lead, maintain, and continuously improve the Quality Management System across the division.
• Ensure alignment with:
• ISO 9001 requirements
• Corporate quality standards
• Regional and global quality requirements
• Serve as the primary QMS subject matter expert for plant departments and leadership.
• Develop, revise, maintain, and govern quality procedures, standards, and controls.
• Promote risk-based decision making and process-oriented quality management.

Calibration Program Management

• Lead the division-wide calibration program as the primary technical expert.
• Manage relationships with calibration vendors and internal stakeholders.
• Ensure compliance with calibration requirements and industry standards.
• Develop strategies that improve calibration sustainability, efficiency, and effectiveness.
• Monitor calibration status and ensure timely completion of equipment calibrations.
• Evaluate compliance risks associated with measurement systems and calibrated equipment.

Records Management & Document Control

• Govern quality records management systems and retention practices.
• Ensure compliance with organizational, regulatory, and ISO record retention requirements.
• Manage document control systems and electronic quality records.
• Establish standards for documentation consistency, accessibility, and traceability.
• Support migration and integration of quality documentation into electronic systems.

Audit & Compliance Management

• Plan, coordinate, and lead internal and external audit activities.
• Maintain compliance with ISO 9001 standards and quality requirements.
• Manage:
• Audit scheduling
• Audit execution
• Findings documentation
• Corrective action tracking
• Audit closure activities
• Support regulatory inspections and quality reviews.
• Communicate audit findings, risks, and improvement opportunities to stakeholders.

Corrective Action & Root Cause Analysis

• Own corrective action management processes within quality management systems.
• Guide teams through:
• Root Cause Analysis (RCA)
• Corrective Action Development
• Preventive Action Planning
• Effectiveness Verification
• Promote best practices in problem solving and issue resolution.
• Ensure corrective actions address underlying causes and prevent recurrence.

Continuous Improvement & Risk Management

• Drive implementation of:
• PDCA (Plan-Do-Check-Act)
• Risk Assessments
• Process-Based Improvement Methodologies
• Identify opportunities to improve quality processes, systems, and compliance programs.
• Support Lean and continuous improvement initiatives.
• Facilitate risk identification, mitigation planning, and quality governance activities.
• Promote a culture of operational excellence and quality ownership.

Training & Capability Development

• Support development of auditor competency and certification programs.
• Deliver training on:
• QMS requirements
• ISO standards
• Audit processes
• Calibration compliance
• Record management
• Mentor stakeholders on quality system best practices.
• Improve organizational quality awareness and capability.

Cross-Functional Collaboration

• Partner with:
• Plant Leadership
• Manufacturing Teams
• Engineering Teams
• Quality Departments
• External Auditors
• Calibration Vendors
• Build consensus around quality initiatives and compliance requirements.
• Support enterprise quality objectives and improvement programs.
• Communicate quality risks, recommendations, and performance results effectively.

Required Qualifications

• Bachelor's degree or equivalent professional experience.
• 0-6 years of experience in:
• Quality Systems
• Manufacturing Quality
• Quality Assurance
• Process Improvement
• Compliance Management
• Knowledge of ISO quality standards and quality management principles.
• Strong analytical and problem-solving abilities.
• Ability to work independently and influence stakeholders across multiple organizational levels.
• Excellent communication and collaboration skills.

Preferred Qualifications

• ISO 9001 Internal Auditor certification.
• Experience participating in or leading quality audits.
• Experience supporting corrective action programs.
• Knowledge of manufacturing quality systems and compliance frameworks.
• Experience with calibration program administration.
• Familiarity with electronic quality management systems (eQMS).