Commercial Quality Assistant Manager – Handling, Storage & Distribution
On-site · North Ryde, New South Wales, Australia
Job Summary
Position Purpose: Provide effective Quality support to ANZ Loan Kit & Set Creation Operations, Facilities (EFM), 3PL and other stakeholders to ensure J&J products are stored and distributed with a high focus on Quality & Compliance. Lead the execution of Quality Management System elements applicable to DePuy Synthes National Warehouses, Loaner Standard, and ensure distribution practices meet regulatory requirements. Manage activities including material & product controls, temperature & humidity controls, facilities validation, equipment validation, supplier quality management (agreements, audits, NCs, CAPA, change controls), supplier engagement/disengagement, SOP/WI development and approvals, and continuous improvements to QA performance in supply chain distribution.
Required Qualifications
- Bachelor’s degree or higher in Health, Science, Pharmacy, Engineering or related field
- 5 or more years relevant experience in healthcare or related industry
- Strong understanding of ISO 9001, ISO 13485 and regulatory requirements for medical device warehousing & distribution in AU/NZ
- Skills in Audit Management, Compliance, CAPA, Change Controls, SOP development, Quality Agreements
- Ability to lead quality activities, audits, and supplier engagement
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