Product Audit Specialist

Role Overview

The Product Audit Specialist will be responsible for carrying out thorough product evaluations to verify adherence to company quality standards, applicable regulations, technical requirements, and customer expectations throughout the entire product lifecycle. This role involves planning and performing audits, reviewing manufacturing and quality documentation, analyzing compliance, identifying gaps, and recommending effective corrective and preventive measures to enhance product quality and operational excellence.

Key Responsibilities

• Execute detailed product audits and assess compliance with quality benchmarks and regulatory frameworks.
• Review and verify manufacturing and quality documentation for accuracy and completeness.
• Identify quality deficiencies and suggest corrective and preventive actions to improve performance.
• Collaborate with various departments including quality assurance, engineering, manufacturing, regulatory affairs, supply chain, and operations to maintain consistent product quality.
• Analyze audit results, prepare comprehensive reports, monitor corrective actions, and support supplier audits.
• Assess process effectiveness, track quality metrics, and lead continuous improvement initiatives to ensure product reliability and regulatory compliance.

Qualifications and Experience

• Bachelor's degree in Quality Management, Engineering, Manufacturing, Industrial Engineering, Operations Management, Business Administration, or a related discipline.
• Proven background in product auditing, quality assurance, quality control, compliance, manufacturing, supplier quality, or regulatory affairs.
• Strong grasp of quality management systems (QMS), product auditing techniques, compliance standards, risk management, and CAPA principles.
• Experience conducting diverse audits including internal, external, product compliance, supplier, process, and documentation audits as well as root cause analysis.
• Knowledge of international standards and regulatory frameworks such as ISO 9001, ISO 13485, GMP, FDA regulations, IATF 16949, AS9100, or other relevant industry standards.
• Proficiency with Microsoft Office Suite and familiarity with quality management systems, ERP software, audit management tools, document control systems, and business intelligence platforms like Power BI or Tableau.
• Strong analytical and problem-solving skills to evaluate evidence, detect compliance gaps, assess operational risks, and provide practical recommendations.
• Excellent communication and stakeholder management abilities to document findings, compile audit reports, and collaborate across departments and senior leadership.
• Experience supporting regulatory inspections, certification audits, new product launches (NPI), supplier qualifications, and quality improvement projects is a plus.
• Understanding of Lean Manufacturing, Lean Six Sigma, Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), and risk-based auditing is advantageous.
• Professional certifications such as ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 9001 Lead Auditor, or Lean Six Sigma Green Belt are considered beneficial.
• A proactive, detail-oriented approach demonstrating integrity and commitment to maintaining product quality, regulatory compliance, and continuous improvement for operational excellence and customer trust.