Job Description

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, in order to meet the expectations of customers and patients.

Key Responsibilities

- Lead the execution of Quality Management System elements applicable to DePuy Synthes National Warehouses, Loan Kits and Set Creation Operations in Australia/New Zealand, including the DePuy Synthes Loaner Standard.
- Ensure that products distributed by DePuy Synthes in ANZ are stored and distributed in accordance with applicable standards, and regulatory requirements, including: Handling, Storage & Distribution; Material & Product Controls; Temperature & Humidity Controls; Facilities, Utilities & Equipment Validation.
- Ensure that Johnson and Johnson storage facilities are designed, constructed, qualified, and maintained in accordance with applicable standards, product and regulatory requirements.
- Support Supply Chain related Facilities activities including new & changes to DC's, facility validation & mapping, maintenance & calibration, pest control & cleaning.
- Support equipment validation activities.
- Ensure effective quality management of Supply Chain & Facilities suppliers, including establishing & maintaining Quality Agreements, monitoring of change controls, NC's, & CAPA's, conducting or supporting audits, and responding to audit observations.
- Lead Quality activities for supplier engagement & disengagement.
- Support the response,



remediation & closure of audit observations for supplier audits.
- Support Supply Chain & Facilities related document (SOP's, WI's, etc.) development, reviews & provide Quality approvals.
- Provide leadership & guidance for the timely resolution & approval of NC's, CAPA's & Change Controls raised by Supply Chain and Facilities related to processes, equipment and facilities.
- Drive timely and effective resolution of Quality & Compliance issues relating to the distribution of DePuy Synthes products.
- Drive continuous improvements in DePuy Synthes Supply Chain Quality performance.

Required Qualifications

- Bachelor's degree required (Health, Science, Pharmacy, Engineering).
- Minimum 5 years relevant experience in healthcare or related industry.
- Solid understanding of Quality requirements, systems and regulations.
- Deep understanding of ISO 9001, ISO 13485 and other international quality accreditation standards.
- Deep understanding of quality and regulatory requirements for medical device warehousing & distribution across Australia and New Zealand.

Preferred Skills

- Audit Management
- Business Savvy
- Coaching
- Communication
- Compliance Management
- Continuous Improvement
- Fact‑Based Decision Making
- Issue Escalation
- Problem Solving
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Regulatory Environment
- Standard Operating Procedure (SOP)

Additional Information

Location: North Ryde, New South Wales, Australia. Job Category: Professional. All job posting locations: North Ryde, New South Wales, Australia.

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📌 Commercial Quality Assistant Manager – Handling, Storage & Distribution (City of Ryde)
🏢 7515-Johnson & Johnson MedicalLegal Entity
📍 City of Ryde