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.
About the Role An established pharmaceutical manufacturing site is seeking a QC Analyst (Biochemistry) to join its Quality Control team. This role plays a key part in ensuring products meet strict quality, safety, and regulatory standards within a GMP-regulated laboratory environment. You’ll be responsible for performing routine and non-routine analytical testing, maintaining accurate documentation, and supporting continuous improvement across QC operations. Key Responsibilities Perform routine biochemical and analytical testing in line with approved methods and SOPs Ensure all testing complies with GMP, GDP, and quality system requirements Accurately document results and enter data into LIMS Investigate out-of-specification, invalid, or atypical results Maintain laboratory equipment, including calibration and troubleshooting Support method validation, documentation updates, and continuous improvement initiatives Contribute to laboratory safety, housekeeping, and 5S standards Collaborate with cross-functional teams to support production and quality outcomes About You Degree in Science, Biochemistry, Chemistry, or a related discipline Experience working in a GMP-regulated laboratory (pharma, biotech, or similar) Hands-on experience with biochemical or analytical testing techniques Strong attention to detail and commitment to quality and compliance Comfortable working with documentation, procedures, and regulated systems Able to work well in a structured, team-based environment What’s on Offer Join a well-established, regulated manufacturing environment Exposure to a broad range of QC activities and techniques Supportive team and strong quality culture Ongoing training and development opportunities Secure, long-term role with stability and career progression How to Apply If you’re a QC Analyst looking to grow your experience within a regulated pharmaceutical environment, we’d love to hear from you. Apply now or reach out for a confidential discussion.
