Commercial Quality Assistant Manager – Handling, Storage & Distribution
jj · North Ryde
Job description
About the role
Provide effective quality support to ANZ Loan Kit & Set Creation Operations, facilities, 3PL and other stakeholders to ensure Johnson & Johnson products are stored and distributed with a high focus on quality and compliance.
Key responsibilities
- Lead execution of Quality Management System elements for DePuy Synthes national warehouses, loan kits and set creation operations in Australia/New Zealand.
- Ensure storage and distribution of products meet applicable standards, regulatory requirements and DePuy Synthes Loaner Standard.
- Support facilities activities including design, construction, qualification, validation, maintenance, calibration, pest control and cleaning.
- Manage quality agreements and oversight of 3PL, transportation, calibration and maintenance suppliers.
- Conduct or support supplier audits, handle audit observations, and drive corrective and preventive actions.
- Develop, review and approve supply‑chain related documents (SOPs, work instructions) to ensure compliance.
Required profile
- Bachelor’s degree in health, science, pharmacy, engineering or related field.
- 5+ years of relevant experience in healthcare, medical device operations or manufacturing.
- Strong understanding of quality requirements, systems and regulations for medical device warehousing and distribution in ANZ.
Required skills
- ISO 9001 and ISO 13485 standards.
- Quality Management Systems (QMS) implementation.
- Audit management and supplier quality oversight.
- CAPA, NC and change control processes.
- Facility and equipment validation.
- Development and approval of SOPs and work instructions.
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Published 8 hours ago
Expires 1 month from now
5 views · 0 interested
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jj
North Ryde