Job Function
Quality
Job Sub Function
Customer/Commercial Quality
Job Category
Professional
All Job Posting Locations
North Ryde, New South Wales, Australia
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. 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.
Requirements
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:
Establish & maintain Quality Agreements with suppliers e.g. 3PL's, Transportation Service Providers, calibration & maintenance, pest control & cleaning.
Ensure effective Quality management & monitoring of Supply Chain suppliers & Facilities suppliers, including oversight of change controls, non-conformances, & CAPAs.
Conduct or support audits of suppliers according to applicable standards, regulations, and Quality Agreements.
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 to ensure product quality and compliance with applicable standards & regulations.
Provide leadership & guidance for the timely resolution & approval of non-conformances, CAPAs & 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.
Skills, Knowledge And Experience
Preferred minimum education
Bachelor's degree is required
Preferred area of study
Health, Science, Pharmacy, Engineering
Preferred related industry experience
Healthcare company, operations or manufacturing
Knowledge And Experience
5 or more years relevant experience preferably in the healthcare or related industry.
A strong understanding of Quality requirements, systems and regulations is required.
Deep understanding of the importance and principles of quality systems and assurance/control, and understanding of International quality accreditation standards e.g. ISO ****, ISO *****.
Deep understanding of quality and regulatory requirements for medical device warehousing & distribution across Australia and Recent Zealand.
Required Skills
Audit Management
Business Savvy
Coaching
Communication
Compliance Management
Continuous Improvement
Fact-Based Decision Making
ISO ****
Issue Escalation
Problem Solving
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Regulatory Environment
Standard Operating Procedure (SOP)
Preferred Skills
Audit Management
Business Savvy
Coaching
Communication
Compliance Management
Continuous Improvement
Fact-Based Decision Making
ISO ****
Issue Escalation
Problem Solving
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Regulatory Environment
Standard Operating Procedure (SOP)
#J-*****-Ljbffr

📌 Commercial Quality Assistant Manager – Handling, Storage & Distribution (New South Wales)
🏢 Johnson & Johnson MedTech
📍 New South Wales