Quality Manager

IonOpticks; Melbourne; On-site; AUD 120,000 - 160,000; Full time

Job summary

IonOpticks, Melbourne-based leader in chromatography and proteomics, seeks a Quality Manager to own the QMS and steer ISO 9001:2026. You will lead audits, CAPA, document control, and risk management while partnering with production, product development and operations to embed quality across markets.

You will coach the Quality Coordinator, build practical systems, and champion a no-blame quality culture that scales with the business.

Job description

Exciting opportunity to join an Australian-based technology company on a global mission to revolutionise the field of chromatography and proteomics.

Who we are

IonOpticks is an innovative company revolutionising chromatography and medical research following the successful commercialisation of its novel chromatography columns. Established in 2017, right here in Melbourne, our technology has rapidly enabled us to be the global leader in the manufacture of columns for LC-MS applications. Our growing list of products have now been adopted by leading mass spectrometry laboratories in the pharmaceutical, academic and industry sectors worldwide.

The role

We are on the look out for a dedicated Quality Manager to own our ISO 9001 Quality Management System and help shape how quality works as we scale.

This is a hands-on leadership role in a small team. You’ll lead our transition to ISO 9001:2026, run internal and external audits, and own CAPA, document control and risk management. You’ll work closely with production, product development and operational teams, and advise leadership directly on quality and regulatory risk across markets.

You’ll have real influence here. You’ll build systems that are practical and proportionate, coach a Quality Coordinator, and make quality something the whole business owns. If you enjoy being close to the product and want to shape a QMS rather than just maintain one, we’d love to hear from you.

Key responsibility Areas

• QMS and Certification: Oversee the development, implementation, and maintenance of the QMS in accordance with ISO 9001 and lead the ISO 9001:2026 transition.
• Audit Management: Plan and conduct the internal audit programme, and host certification and surveillance audits through to close-out of findings.
• Non-conformance, CAPA and Improvement: Run the non-conformance, deviation and CAPA process, and use quality data and trends to identify and lead improvement projects.
• Risk, Change and Equipment Control: Maintain the quality risk management process, and oversee change control, equipment qualification, calibration and preventive maintenance.
• Document Control: Maintain an accurate, inspection-ready document control system, working with process owners to write procedures that reflect how work is actually done.
• Customer Satisfaction: Manage quality-related complaints and returns, and work with customer-facing teams to make sure customer requirements are understood and met.
• Training and Support: Develop and deliver QMS training, and help teams apply QMS processes day to day.
• Leadership and Quality Culture: Lead and coach the Quality Coordinator, and promote a practical, no-blame quality culture across the organisation.

Key selection criteria

• Bachelor's degree in Science, Engineering, Quality Management or a related field.
• 5+ years in quality management in a manufacturing environment, with at least 2 years leading a QMS.
• Hands-on experience maintaining ISO 9001 certification (or similar) and hosting external audits.
• Experience leading, coaching or mentoring staff.
• Ability to influence and work across production, product development and operational teams.
• Strong root cause analysis and CAPA skills.
• Lead or internal auditor qualification for ISO 9001.
• Experience with Lean or Six Sigma methodologies.
• Experience with laboratory consumables, chromatography or analytical instrumentation.
• Experience with equipment qualification and calibration programmes.
• Familiarity with eQMS or quality management tools.

Why IonOpticks?

• Our lean and rapidly growing team consists of high achievers, focused on developing new technologies in response to global market demand.
• Our people are our priority and we are committed to supporting the ongoing personal and professional development of our team members.
• We take pride in our culture that supports diversity and flexible working arrangements to ensure our team members continue to love doing what they do best.
• We are a values-driven organisation where we thrive together, pursue excellence, continuously evolve, and create lasting impact.