Head of Quality

The Opportunity This role provides the opportunity to make a real impact across the business: lead quality during a critical growth phase, shape systems, teams, and processes that directly influence patient outcomes.

Play a highly visible, high-impact role: lead quality during a critical growth phase, shape systems, teams, and processes that directly influence 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.

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 leadership 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.

For a confidential conversation about this role, please contact Grace Bitodi at

gbitodi@onqrecruitment.com.au .

#J-18808-Ljbffr