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 9001, ISO 13485.
- Deep understanding of quality and regulatory requirements for medical device warehousing & distribution across Australia and New Zealand.
Required Skills
- Audit Management
- Business Savvy
- Coaching
- Communication
- Compliance Management
- Continuous Improvement
- Fact-Based Decision Making
- ISO 9001
- 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 9001
- Issue Escalation
- Problem Solving
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Regulatory Environment
- Standard Operating Procedure (SOP)
Commercial Quality Assistant Manager – Handling, Storage & Distribution in Ryde employer: Johnson & Johnson MedTech
At Johnson & Johnson, we pride ourselves on being an exceptional employer, particularly for the Senior Loan Kit Team Lead role in Norwood, South Australia. Our inclusive work culture fosters diversity and individual merit, while our commitment to employee growth is evident through continuous training, award-winning leadership development programs, and generous benefits like extended parental leave and wellness support. Join us to be part of a team that not only drives operational excellence but also profoundly impacts health for humanity.
