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.
Benefits Contract role with immediate start High-impact GDP / 3PL quality project Flexible hybrid working - 3 days in office Work with an experienced quality team About the company A global pharmaceutical organisation with a strong presence across Australia and international markets. The business is highly regarded for its commitment to quality, patient safety, and regulatory excellence, operating within a mature and well-established Quality Management framework. About the opportunity This is a contract Senior Quality Associate role supporting a critical logistics and distribution project. You will work closely with the local Quality Manager and Quality team, providing hands-on quality assurance support across external logistics partners. The role is delivery-focused, with a strong emphasis on GDP compliance, documentation, and vendor quality oversight. This position plays a key role in ensuring continuity, compliance, and risk mitigation during a defined project period. Duties Transition 3PL providers from a quality perspective Support GDP compliance across distribution activities Review and maintain SOPs and quality documentation Manage deviations, change controls and CAPAs Support audits and vendor quality activities Deliver quality training to external partners Partner closely with internal Quality stakeholders Skills and Experience Pharmaceutical quality experience GDP and logistics exposure 3PL / vendor quality oversight SOPs, deviations, CAPAs Full work rights for Australia Ability to commit to a minimum of 8 months Culture Professional, collaborative, quality-driven, and pragmatic. How to Apply Click apply and your application will be reviewed by Laura Longstaff, Director. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare – Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. Medical Affairs & Life Sciences Recruitment – Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific Commercial Recruitment – Marketing, Sales, Analytics, Government and External Affairs Business Operations & Infrastructure Recruitment – Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse Clinical Care Recruitment – Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing For more job opportunities, visit www.hpgconnect.com
Benefits • Permanent, full-time opportunity • Broad, hands-on role with real ownership and visibility • Collaborative, small-team environment with exposure across the business About the company This opportunity sits within a growing, specialty pharmaceutical organisation operating across Australia and New Zealand. The business focuses on the commercialisation and distribution of medicines across several therapeutic areas. Locally, the team is lean, agile, and in a growth phase, offering genuine influence and autonomy. About the opportunity This is a newly created Quality and Medical Operations Specialist role. The position offers broad responsibility across quality systems, pharmacovigilance, and medical, making it ideal for someone who enjoys being hands-on and building structure in a growing organisation. You will play a key role in ensuring compliance with TGA, GMP, and PV requirements while partnering closely with regulatory, commercial, and external stakeholders. Duties • Own and manage the local QMS including document control, deviations, change control, CAPAs, and continuous improvement activities • Manage product quality complaints, adverse quality events, and investigations in line with TGA expectations • Coordinate quality documentation for imported products, manufacturers, suppliers, and distributors • Act as the local QPPV overseeing adverse event reporting and pharmacovigilance obligations • Submit adverse events to the TGA and maintain an effective PV system • Support readiness for TGA audits and inspections, including preparation and follow-up actions • Develop, review, and maintain SOPs, work instructions, and quality policies • Partner with Sales and Marketing teams to embed quality processes into commercial activities • Support medical information activities over time, with structured training provided • Collaborate with Regulatory Affairs on GMP clearances, product changes, and quality-related submissions Skills and experience • Tertiary qualification in Pharmaceutical Sciences, Quality Assurance, or a related discipline • Experience working within a pharmaceutical Quality Management System • Solid understanding of TGA, GMP, and PV requirements in a commercial environment • Experience developing and maintaining SOPs and quality documentation • Strong attention to detail with a practical, solutions-focused mindset • Comfortable working autonomously and building processes where they do not yet exist • Confident communicator able to engage across technical and non-technical stakeholders Culture This organisation offers a down-to-earth, collaborative culture where people are trusted to take ownership. How to apply If this sounds like your next move, click apply or contact Eve Cooke ecooke@hpgconnect.com for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits across Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care, spanning Medical Affairs, Regulatory Affairs, Quality, Pharmacovigilance, Commercial, and Operations roles.
