Quality Manager - Medical Devices & QMS Leader

Add Staff, Inc; Sydney; On-site; AUD 120,000 - 190,000; Full time

Job summary

Grifols is seeking a Quality Manager to ensure compliant distribution of medical devices and IVD products, maintain the affiliate's Quality Management System, and act as the key local contact for quality and regulatory matters reporting to Corporate Quality in Spain.

You will implement the Quality System, manage distribution licenses, coordinate recalls and CAPAs, and collaborate with Regulatory, General Manager, and Corporate Quality teams in a global setting.

Qualifications

• 3+ years of experience in Quality or Regulatory roles within a multinational environment.
• Experience with medical devices or IVDs preferred.
• Experience implementing or maintaining a Quality System (ISO 9001 desirable).

Responsibilities

• Implement, maintain, and improve the affiliate's Quality System in line with corporate policies and Korean regulatory requirements.
• Manage product distribution activities (storage, shipping, transport) and ensure licenses remain valid.
• Act as in-country quality contact for customers, distributors, and authorities; coordinate complaint management with Grifols sites.
• Qualify suppliers; perform periodic assessments; execute audits or desk audits as required.
• Coordinate recalls, product incidents, deviations, CAPAs, and change controls with timely escalation.
• Attend internal and external audits, including government inspections and customer visits.
• Review and approve promotional materials from a local regulatory perspective.
• Elaborate and approve SOPs and Work Instructions per corporate standards.
• Collaborate with local Regulatory Specialist, GM, and Corporate Quality teams; participate in weekly/monthly global meetings.

Skills

Autonomy

Communication

Regulatory interactions

Audits

Corrective actions (CAPAs)

Education

Degree in Pharmacy

Tools

SAP

Job description

Grifols is seeking a Quality Manager to ensure compliant distribution of medical devices and IVD products, maintain the affiliate's Quality Management System, and act as the key local contact for quality and regulatory matters reporting to Corporate Quality in Spain.

You will implement the Quality System, manage distribution licenses, coordinate recalls and CAPAs, and collaborate with Regulatory, General Manager, and Corporate Quality teams in a global setting.