Product Audit Specialist

About the role

The Product Audit Specialist ensures that all products meet the organization’s quality standards, regulatory requirements, and customer expectations throughout their lifecycle. You will work closely with cross‑functional teams to drive product reliability and compliance.

Key responsibilities

• Plan, execute and document comprehensive product audits across manufacturing and supply‑chain processes.
• Review technical specifications, quality documentation and regulatory filings to assess compliance.
• Identify quality gaps, recommend corrective and preventive actions, and monitor their implementation.
• Prepare detailed audit reports and present findings to engineering, operations and senior management.
• Support supplier audits, new product introductions and regulatory inspections.
• Track quality metrics, assess process effectiveness and lead continuous‑improvement initiatives.

Required profile

• Bachelor’s degree in Quality Management, Engineering, Industrial Engineering, Operations Management or a related field.
• Proven experience in product auditing, quality assurance, compliance or regulatory affairs.
• Strong knowledge of quality management systems, risk management, CAPA and continuous‑improvement principles.
• Familiarity with international standards such as ISO 9001, ISO 13485, GMP, FDA regulations, IATF 16949 or AS9100.
• Excellent analytical, problem‑solving and stakeholder‑management skills.

Required skills

• Microsoft Office Suite
• Quality Management Systems (QMS)
• ERP platforms
• Audit management software
• Document control systems
• Power BI or Tableau
• ISO 9001, ISO 13485, GMP, FDA regulations, IATF 16949, AS9100
• Lean Manufacturing, Lean Six Sigma
• Statistical Process Control (SPC)
• Failure Mode and Effects Analysis (FMEA)