Benefits End-to-end ownership across the medical device lifecycle High-visibility partnership with Product Development Real influence over design assurance decisions Exposure to complex, patient-impacting technology About the Company A fast-growing global MedTech developing advanced implantable devices. Operating across Australia and the US, the organisation combines strong technical leadership with a collaborative, cross-functional structure and a reputation for innovation and high standards. About the Opportunity This Senior Design Assurance Engineer role sits within Quality and partners closely with Product Development. You’ll own design assurance across new product development and selected sustaining activities, ensuring design controls, risk management, and verification are practical, compliant, and effective. You’ll collaborate alongside a confident, high-calibre team, playing a key role in decision-making, risk mitigation, and keeping projects moving in a fast-paced environment. This role directly shapes product quality, regulatory outcomes, and how design assurance evolves as the organisation scales. Duties Own design assurance across development programs Review and approve design documentation and reports Lead risk management and challenge decisions Partner closely with Product Development Support verification, validation, and design changes Provide quality input to sustaining activities Skills & Experience Engineering or technical degree Medical device design assurance exposure Design controls and risk management Strong stakeholder engagement Culture Collaborative, fast-moving, and technically driven; ideal for someone who enjoys ownership, influence, and working shoulder-to-shoulder with strong teams.
The Opportunity An established, highly regulated manufacturing organisation is seeking a Senior Operational Services Associate to support critical manufacturing operations within a complex production environment. This role plays a key part in deviation management, change management, and cross-functional collaboration, helping ensure manufacturing activities remain compliant, efficient, and continuously improving. You’ll work closely with Manufacturing, Quality, and Technical teams, acting as a subject matter expert across investigations, CAPAs, and GxP change initiatives. Key Responsibilities Lead and manage deviation investigations across manufacturing operations Facilitate root cause analysis and drive investigations through to closure Develop, manage, and track CAPAs, ensuring timely completion Partner with Quality and Manufacturing teams to assess risk and impact Coordinate and lead GxP change management activities Support cross-functional projects and operational improvements Monitor investigation and change metrics, escalating risks where required Maintain strong documentation standards in line with regulatory requirements About You You’ll be a confident operator in regulated manufacturing environments, comfortable working across multiple stakeholders and priorities. You will bring: A tertiary qualification in Science or Engineering 5–10 years’ experience in pharmaceutical, biotechnology, or biological manufacturing Experience in deviation investigations, CAPA management, and change management Strong understanding of GxP environments Solid communication and stakeholder engagement skills The ability to manage timelines, priorities, and competing demands Why Apply? Join a well-established, values-driven organisation Work in a highly technical, regulated environment with real impact Be part of a collaborative team supporting critical manufacturing outcomes How to Apply If you’re looking to step into a senior operational role within regulated manufacturing, we’d love to hear from you. Please contact Jo Turner, Divisional Manager on 0488 807 377 for a confidential discussion or APPLY NOW
