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Commercial Quality Assistant Manager – Handling, Storage & Distribution

jj · North Ryde

New
🇬🇧 English
ISO 9001 ISO 13485 Quality Management Systems Audit Management CAPA NC Change Control Facility Validation Equipment Validation

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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Source : ats:workday

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Published 8 hours ago

Expires 1 month from now

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jj

North Ryde