Position Objective
The Quality Assurance Lead is responsible for developing, implementing and overseeing Quality Assurance and Quality Control activities, ensuring the effective implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485, applicable GMP requirements, and EU MDR obligations.
This role provides operational leadership of the Quality function, combining quality system governance, manufacturing and cleanroom oversight, and people leadership. The QA Lead supports Clients transition from R&D to scalable medical device manufacturing, ensuring quality compliance across production, validation, and inspection activities.
The QA Lead acts as the ISO 13485 Management Representative and Person Responsible for Regulatory Compliance (PPRC) under the EU MDR.
Organisation Information
Client is a multi‐award‐winning, VC‐funded Australian MedTech company developing novel biosensor technologies to improve fetal monitoring during childbirth. Client operates within a highly regulated medical device environment and is progressing from development into manufacturing and commercial readiness.
Position Responsibilities
We may from time to time vary or modify your duties but only to those duties for which you have the skill and competence.
Quality Leadership & Governance
* Provide overall leadership and oversight of the Quality function to ensure continued compliance with ISO 13485 and applicable regulatory requirements
* Act as Management Representative, ensuring QMS processes are implemented, maintained, and effective
* Prepare and present quality system performance inputs for Management Review
* Promote quality awareness and regulatory compliance across the organisation
* Escalate quality system risks and systemic issues to Top Management as required
* Act as a Quality Expert and advise Top Management on key regulatory and quality requirements and initiatives applicable to the company.
Quality Management System (QMS)
* Implement and maintain the Quality Management System in line with ISO 13485 and internal procedures
* Oversee document control, record retention, training systems, and quality data integrity
* Ensure Non‐Conformance (NCR), CAPA, change control, and risk management processes are functioning effectively
* Review and approve quality system documentation where required
* Ensure ongoing audit readiness of the organisation
Manufacturing, Cleanroom & Process Quality
* Provide quality oversight of manufacturing operations to ensure compliance with approved procedures and specifications
* Oversee cleanroom‐related quality activities, including:
* Environmental monitoring programmes
* Gowning, contamination control, and cleanroom behaviour
* Cleaning, disinfection, and housekeeping processes
* Ensure manufacturing documentation, batch records, and inspection data meet quality and regulatory requirements
* Support process transfer, scale‐up, and continuous improvement initiatives
Validation, NPI, Design Transfer & Change Control
* Provide quality oversight and act as a Quality Subject Matter Expert (SME) for New Product Introduction (NPI), Change Control and design transfer activities transitioning products from development into manufacturing
* Driving key projects to implement quality control methods and process controls to improve consistency in Clients flagship biosensor device.
* Ensure design transfer is planned, executed, and documented in accordance with the QMS, including confirmation of manufacturing readiness and completed validation prior to routine production
* Oversee Change Control activities impacting product, process, equipment, facilities, or quality systems, ensuring quality, validation, and regulatory impacts are assessed and appropriately managed
* Provide oversight of validation activities to ensure manufacturing processes, equipment, methods, and environments are fit for intended use
* Ensure execution and maintenance of the Validation Master Plan (VMP)
* Review and approve validation strategies, protocols, and reports, including IQ/OQ/PQ, process and method validation
* Provide technical oversight to the Quality & Validation Specialist and escalate risks impacting quality, timelines, or compliance as required
Audit & Compliance Activities
* Support and lead preparation for internal audits, external audits, and regulatory inspections
* Act as a key quality contact during audits and inspections
* Ensure audit findings, CAPAs, and corrective actions are addressed and closed in a timely manner
* Ensure quality inspection and monitoring data are available, complete, and traceable
Leadership & People Management
* Provide direct line management: set priorities, allocate workload, and provide clear role direction across the Quality team
* Support recruitment, onboarding, training, competency management, and performance development
* Act as first point of escalation for operational quality issues
* Foster a strong, practical quality culture within manufacturing, QC, and validation teams
Cross‐Functional Collaboration
* Work closely with Manufacturing, R&D, Process Development, Supply Chain, and Regulatory Affairs
* Provide quality input into change control, investigations, and improvement initiatives
* Support cross‐functional decision‐making with clear, evidence‐based quality assessments
Qualifications / Licences / Certificates
* Bachelor's degree in Science, Engineering, Biotechnology, or a related discipline
* Auditor qualification (internal or lead auditor) – desirable
Relevant Experience, Skills & Knowledge
* Demonstrated experience in a medical device or similarly regulated quality environment
* Proven experience overseeing QC, QA, and validation activities
* Demonstrated experience with cleanroom operations
* Strong working knowledge of ISO 13485, GMP principles, and quality system processes
* Experience leading or supervising quality teams in a manufacturing environment
* Strong documentation discipline, analytical skills, and problem‐solving capability
* Ability to manage multiple priorities in a fast‐paced start‐up / scale‐up environment
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