Quality Assurance Manager

Reports To: Global QA/RA DirectorDirect Reports: Australia-based QA TeamEmployment Type: Hybrid, Full-time
Position SummaryThe QA Manager is responsible for leading the day-to-day Quality Assurance function in Australia and managing the local QA team to ensure the effective implementation, maintenance and continuous improvement of Genea Biomedx’s Quality Management System (QMS).Reporting to the Global QA/RA Director, the QA Manager will translate global quality strategy, policies and regulatory requirements into effective local execution. The role will provide leadership and oversight across quality systems, compliance, audits, CAPA, non-conformances, change control, supplier quality, training, document control, manufacturing and product quality activities.As the local QA people manager, the position is responsible for establishing clear priorities, allocating resources, developing team capability and ensuring timely completion of quality activities. The QA Manager will work closely with Regulatory Affairs, Manufacturing, QC, R&D, Supply Chain, Engineering and other global functions to maintain a compliant and effective quality system supporting Genea Biomedx’s medical device operations.
Key Responsibilities1. QA Team Leadership & ManagementLead, manage and develop the Australia-based QA team, including setting objectives, priorities and performance expectations.Allocate QA resources and responsibilities according to business, operational and compliance priorities.Provide coaching, technical guidance and ongoing development to QA team members.Conduct regular team meetings, one-on-one discussions and performance reviews.Monitor team workload, deliverables and timelines and escalate resource or compliance risks to the Global QA/RA Director where appropriate.Build a strong culture of quality, accountability, collaboration and continuous improvement within the QA team.Ensure effective communication and coordination between the Australian QA team and other global QA/RA colleagues.2. Quality Management SystemManage the day-to-day implementation and maintenance of the Genea Biomedx QMS in accordance with applicable regulatory and quality requirements.Ensure compliance with ISO 13485 and other applicable medical device regulations and standards.Oversee key QMS processes including:CAPANon-conformancesDeviationsChange controlDocument and record controlQuality trainingComplaint-related quality activitiesSupplier qualityInternal auditsManagement review inputs and follow-up actionsMonitor QMS performance and identify systemic issues, recurring trends and opportunities for improvement.Ensure quality records and documentation are accurate, complete, traceable and maintained in accordance with applicable requirements.3. Manufacturing & Operational QualityProvide QA oversight and support to manufacturing and operational activities conducted at the Australian site.Work closely with Manufacturing and QC teams to ensure products are manufactured, inspected, tested and released in accordance with approved procedures and specifications.Support investigation and disposition of non-conforming materials, components and products and complaints handlingEnsure appropriate quality oversight of manufacturing process changes, equipment changes, validation activities and production-related deviations.Support product release and quality review activities where required.Partner with Operations to identify and address quality risks without compromising regulatory compliance or product quality.4. CAPA, Non-Conformance & Investigation ManagementEnsure CAPAs, non-conformances, deviations and quality investigations are appropriately initiated, investigated, documented and closed within agreed timelines.Review root-cause analyses and ensure corrective and preventive actions are appropriate and effective.Monitor overdue quality actions and work with responsible departments to ensure timely resolution.Identify recurring or systemic quality issues and escalate significant risks to the Global QA/RA Director.Ensure effectiveness checks are appropriately designed, completed and documented.5. Audit & Inspection ReadinessCoordinate and support internal and external quality audits.Support regulatory inspections and certification audits as required.Ensure the Australian site maintains an appropriate state of inspection readiness.Coordinate responses, corrective actions and follow-up activities arising from audit findings.Support the Global QA/RA Director in maintaining oversight of audit findings, compliance risks and remediation activities.6. Supplier QualitySupport and oversee supplier quality activities in collaboration with Supply Chain and other relevant functions.Ensure appropriate qualification, monitoring and periodic evaluation of critical suppliers.Participate in supplier audits and supplier quality investigations where required.Ensure supplier-related non-conformances and quality issues are appropriately investigated, documented and resolved.Support quality agreements and supplier change management activities as applicable.7. Change Control, Validation & Product Lifecycle SupportProvide QA review and approval for relevant change controls.Ensure quality and regulatory impacts are appropriately assessed before implementation of changes.Support validation and verification activities related to manufacturing processes, equipment, software and quality systems as applicable.Work cross-functionally with R&D, Engineering, Manufacturing, QC and Regulatory Affairs throughout the product lifecycle.Ensure design, manufacturing and quality changes are implemented in a controlled and compliant manner.8. Quality Metrics & Management ReportingEstablish and monitor appropriate quality KPIs and operational metrics.Track trends relating to CAPAs, non-conformances, complaints, audit findings, supplier quality and other relevant quality indicators.Provide regular quality updates and reports to the Global QA/RA Director.Identify significant quality or compliance risks and escalate them promptly.Prepare quality information and analysis to support Management Review and senior management decision-making.9. Training & Quality CultureEnsure employees receive appropriate QMS and quality-related training relevant to their responsibilities.Monitor completion and effectiveness of required quality training.Promote awareness of quality and regulatory responsibilities across the organisation.Partner with functional managers to strengthen quality ownership and accountability outside the QA function.Encourage a practical, risk-based and continuous-improvement approach to quality management.10. Global QA/RA CollaborationWork closely with the Global QA/RA Director to implement Genea Biomedx’s global quality strategy and priorities.Support harmonisation of quality processes and practices across Genea Biomedx operations.Collaborate with Regulatory Affairs to ensure quality activities appropriately support global regulatory requirements.Participate in global QA/RA projects and quality improvement initiatives.Provide local operational insight and recommendations to support global quality decision-making.Qualifications & ExperienceEssentialBachelor’s degree in Science, Engineering, Biomedical Engineering, Life Sciences, Quality Management or a related discipline.Significant Quality Assurance experience within the medical device, IVD, pharmaceutical or other highly regulated life-sciences industry.Strong working knowledge of ISO 13485 and medical device Quality Management Systems.Practical experience managing CAPA, non-conformance, compliants handling, change control, audits, document control and quality investigations.Experience supporting manufacturing or operational quality activities.Demonstrated experience leading, supervising or developing QA professionals.Strong understanding of risk-based quality management principles.Strong written and verbal communication skills.Demonstrated ability to work effectively with cross-functional and geographically dispersed teams.Highly DesirablePrevious experience in a formal QA Manager or Quality Manager position .Experience within the medical device or IVF/ART industry with ISO 13485 QMS environment .Knowledge of Australian TGA medical device requirements.Knowledge or practical experience with US FDA Quality System requirements, EU MDR and/or other international medical device regulatory frameworks.Experience supporting regulatory inspections or external certification audits.Experience with supplier quality management and supplier auditing.Lead Auditor or Internal Auditor qualification.Experience working within a global or multinational organisation.Key CompetenciesPeople leadership and team developmentQuality and compliance mindsetStrong ownership and accountabilitySound judgement and risk-based decision-makingEffective prioritisation and resource managementInvestigation and problem-solving capabilityAttention to detail while maintaining a broader business perspectiveStrong stakeholder management and influencing skillsAbility to challenge constructively and escalate quality concerns appropriatelyAbility to operate effectively in a global, cross-functional environmentKey Working RelationshipsInternalGlobal QA/RA DirectorAustralian QA TeamRegulatory Affairs TeamManufacturingQuality ControlSupply ChainR&D / Product DevelopmentEngineeringCommercial and Product teamsGlobal and regional management teamsExternalCertification and auditing bodiesRegulatory authorities, where appropriateSuppliers and contract manufacturersExternal quality and regulatory consultants