Quality Manager - ISO 9001 QMS

About the role

IonOpticks, an Australian technology company founded in Melbourne in 2017, manufactures chromatography columns for LC-MS applications and is looking for a dedicated Quality Manager. This is a hands-on leadership role in a small team, owning the ISO 9001 Quality Management System and helping shape how quality works as the business scales. You will lead the transition to ISO 9001:2026, run internal and external audits, and advise leadership on quality and regulatory risk.

Key responsibilities

• Oversee the development, implementation and maintenance of the QMS under ISO 9001 and lead the ISO 9001:2026 transition
• Plan and run the internal audit programme and host certification and surveillance audits through to close-out of findings
• Run the non-conformance, deviation and CAPA process and lead improvement projects using quality data and trends
• Maintain the quality risk management process and oversee change control, equipment qualification, calibration and preventive maintenance
• Maintain an inspection-ready document control system and work with process owners to write procedures
• Manage quality-related complaints and returns and work with customer-facing teams on customer requirements
• Develop and deliver QMS training and coach the Quality Coordinator

Required profile

• Bachelor's degree in Science, Engineering, Quality Management or a related field
• 5+ years in quality management in a manufacturing environment, including 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

Desirable

• Lead or internal auditor qualification for ISO 9001
• Lean or Six Sigma experience
• Experience with laboratory consumables, chromatography or analytical instrumentation
• Experience with equipment qualification and calibration programmes
• Familiarity with eQMS or quality management tools

To apply, submit your CV and cover letter through the company's careers page, stating how you meet the key selection criteria.