Senior Quality Manager - Remote, ISO 13485

i-Pharm Consulting; Sydney; Hybrid; AUD 160,000 - 180,000; Full time

Benefits offered by this job

Hybrid/remote work

Flexible hours

Job summary

i-Pharm Consulting seeks a hands-on Quality Manager to lead the Quality function for an established Australian medical device company, based in Sydney. You will own the QMS, drive ISO 13485 compliance, and partner with engineering, regulatory and manufacturing teams to sustain continuous improvement.

This role offers a practical, broad ownership path with direct access to leadership, working across functions, and a hybrid/mostly remote arrangement.

Qualifications

• Hands-on Quality Manager ready to take broad ownership of a QMS.
• Solid ISO 13485 knowledge with FDA, MDSAP and EU MDR exposure.
• Experience leading audits, CAPA, nonconformances and investigations.
• Experience with outsourced manufacturing and cross-functional stakeholders.
• Strong communication and leadership skills.

Responsibilities

• Own, maintain and improve the QMS in line with ISO 13485 and medical device requirements.
• Lead preparation for external audits and inspections; coordinate responses and actions.
• Manage CAPA, nonconformances and investigations with effective corrective actions.
• Oversee quality activities with outsourced manufacturing and offshore partners.
• Collaborate with engineering and regulatory teams to embed quality in daily work.

Skills

QMS ownership

ISO 13485

FDA requirements

MDSAP

EU MDR

Audits & CAPA

Outsourced manufacturing coordination

Job description

i-Pharm Consulting seeks a hands-on Quality Manager to lead the Quality function for an established Australian medical device company, based in Sydney. You will own the QMS, drive ISO 13485 compliance, and partner with engineering, regulatory and manufacturing teams to sustain continuous improvement.

This role offers a practical, broad ownership path with direct access to leadership, working across functions, and a hybrid/mostly remote arrangement.