Commercial Quality Assistant Manager – Handling, Storage & Distribution

About the role

The Commercial Quality Assistant Manager will provide quality support for ANZ Loan Kit & Set Creation Operations, facilities, 3PL and other stakeholders, ensuring J&J products are stored and distributed in compliance with quality and regulatory standards.

Key responsibilities

• Lead execution of QMS elements for DePuy Synthes warehouses, loan kits and set creation operations across Australia and New Zealand.
• Validate storage facilities, equipment, utilities and ensure they meet design, construction and maintenance standards.
• Manage quality agreements with suppliers (3PL, transportation, calibration, pest control) and oversee change controls, NCs and CAPAs.
• Conduct or support supplier audits, drive remediation of observations and approve related documentation.
• Resolve NCs, CAPAs and change controls related to supply‑chain processes, equipment and facilities.

Required profile

• Bachelor’s degree in Health, Science, Pharmacy, Engineering or related field.
• 5+ years of relevant experience in healthcare, operations or manufacturing, with strong knowledge of quality systems and regulations.
• Deep understanding of ISO 9001, ISO 13485 and medical‑device warehousing/distribution requirements in Australia and New Zealand.

Required skills

• ISO 9001
• ISO 13485
• Audit management
• Quality Management Systems (QMS)
• Regulatory compliance
• Standard Operating Procedure (SOP) development and approval