Quality Manager

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

An established Australian medical device company is seeking a hands-on Quality Manager to lead its Quality function and support its operations. Profitable and self-funded, the business combines the agility of a small, engineering-led team with an established quality management system and a strong audit history. Key decisions and QMS ownership sit in Sydney, with manufacturing outsourced offshore and products supplied to international markets.

About the Company

An established Australian medical device company is seeking a hands-on Quality Manager to lead its Quality function and support its operations. Profitable and self-funded, the business combines the agility of a small, engineering-led team with an established quality management system and a strong audit history. Key decisions and QMS ownership sit in Sydney, with manufacturing outsourced offshore and products supplied to international markets.

About the Role

Reporting directly to the business leader, you will take ownership of the Quality Management System and work closely with engineering, regulatory and manufacturing partners to maintain compliance and support business priorities.

This is a practical, hands-on position suited to someone who enjoys broad responsibility, direct access to decision-makers and working across functions.

The business is recruiting a permanent Quality Manager or Immediate Quality Manager Contractor.

This role is a hybrid working model with option of mostly remote work.

Responsibilities

• Own, maintain and continually improve the Quality Management System in line with ISO 13485 and applicable international medical device requirements.
• Lead preparation for external audits and inspections, coordinate responses and ensure timely completion of follow-up actions.
• Manage CAPA, nonconformances and related investigations, ensuring effective corrective actions.
• Oversee quality activities associated with outsourced manufacturing and work collaboratively with offshore manufacturing partners.
• Partner with engineering and regulatory colleagues to ensure quality requirements are embedded in day-to-day activities.
• Maintain accurate, current and effective quality documentation.
• Provide practical guidance on quality risks, compliance priorities and improvement opportunities.
• Coordinate contributions from colleagues supporting Quality and promote accountability across the business.

Required Skills

• Strong experience in medical device quality assurance and practical ownership of a QMS.
• A sound working knowledge of ISO 13485, with experience supporting FDA requirements, MDSAP and EU MDR compliance.
• Hands‑on experience managing audits, CAPA, nonconformances and quality investigations.
• The ability to work effectively with outsourced manufacturers and cross‑functional stakeholders.
• A pragmatic approach to problem‑solving, balancing compliance requirements with operational needs.
• Strong communication skills and the confidence to work directly with business leadership.
• The flexibility to manage varied responsibilities within a small, collaborative team.
• Applications are welcomed from experienced Quality Managers and strong Senior Quality Assurance professionals or Quality Leads ready to step into broader ownership.

Pay range and compensation package

• Salary: $160,000–$180,000 plus superannuation, depending on experience
• Contract rate: Negotiable
• Ownership of an established Quality function within a financially secure Australian medical device business.
• Market leading remuneration package
• Direct access to leadership and the opportunity to influence decisions.
• Broad exposure to international markets and medical device quality requirements.
• Flexible working hours and working‑from‑home arrangements, with Sydney office attendance agreed according to business needs.
• An immediate-start six-month contract option, with rate negotiated according to experience and scope.