Head of Quality

On Q Recruitment is partnering with an innovative medical technology organisation developing cutting-edge imaging technology with the potential to transform outcomes for cancer patients. As the business transition from research to commercial operations, they are looking for a Head of Quality to scale quality operations, lead the quality team, ensure regulatory readiness, and embed a strong culture of quality across the organisation.

The Opportunity

This role provides the opportunity to make a real impact across the business:

• Play a highly visible, high-impact role : Lead quality during a critical growth phase, shaping systems, teams, and processes that directly influence our client’s success and impact on patient outcomes.
• Strengthen and evolve the quality system : Enhance and mature fit-for-purpose quality frameworks to ensure regulatory compliance, support upcoming audits and inspections, and position the company for long-term success.
• Build and develop a high-performing quality team : Mentor and grow a skilled team capable of delivering technical excellence and operational efficiency.
• Act as a senior cross-functional leader : Collaborate with research and development, operations, clinical, and executive teams to inform product, operational, and strategic decisions through the lens of quality.
• Values-driven environment: Work in a culture that prioritises a patient-first mindset, psychological safety, knowledge sharing, and collaborative teamwork. People are encouraged to challenge the status quo, work flexibly, and thrive in a supportive, high-trust environment.

Key Responsibilities

• Own, enhance, and scale the QMS in line with ISO 13485, ISO 14971, TGA, and FDA requirements.
• Lead and build a high-performing Quality team while embedding a strong quality culture across the organisation.
• Implement robust design controls, risk management, and post-market surveillance processes.
• Oversee manufacturing and supplier quality, including audits, batch approvals, and CAPA management.
• Lead regulatory inspections and maintain audit readiness.

   

About You

• Over 10 years of quality assurance experience in the medical device industry.
• Demonstrated effective people leaderships skills, and proven experience building and leading high-performing quality teams.
• Proven experience building and scaling an ISO 13485-compliant QMS.
• Strong working knowledge of ISO 13485, ISO 14971, TGA requirements, and US FDA QSR/QMSR.
• Demonstrated track record in leading audits and hosting regulatory inspections,
• Pragmatic, credible, collaborative, and able to influence senior stakeholders effectively.
• Comfortable operating in a growth-stage environment with evolving processes.

This is an exciting opportunity to lead quality at a company on the edge of commercial operations, shaping systems, teams, and processes that will directly influence patient outcomes. For a confidential conversation about this role, please contact Grace Bitodi at gbitodi@onqrecruitment.com.au.