Principal Design Assurance Engineer | Technical Lead | Medical Devices Benefits Operate at Principal level, solving complex technical and design challenges Influence critical decisions across high-risk, implantable medical device development Stay hands-on technically while gaining greater strategic influence and autonomy Across design, systems, risk and V&V – not just Quality Become a technical mentor and help shape Design Assurance capability About the Company Join an innovative Sydney-based medical device organisation developing sophisticated implantable technology for patients globally. You’ll join in a multidisciplinary environment alongside experienced Engineering, Systems, Quality, and Regulatory professionals, contributing to technically complex products where strong engineering judgement is critical. About the Opportunity This isn’t a traditional Quality role. It’s a Principal level technical position within Design Assurance for an experienced engineer who enjoys getting into the difficult problems: challenging designs, interrogating technical evidence and helping teams find the right path when the answer isn’t obvious. You’ll collaborate with Product Development to ensure design decisions, risk controls and V&V strategies are technically robust, and you’ll play a key role when regulators come asking questions. Your influence will come from technical credibility, sound judgement and the ability to guide others through complex problems. What You’ll Be Doing Acting as a senior technical voice across complex medical device development programs Challenging and guiding Engineering on critical design and product decisions Applying design controls and ISO14971 risk management throughout development Reviewing requirements, architecture, risk controls and V&V evidence Contributing substantially to complex technical investigations alongside Product Development Responding to regulator questions and supporting regulatory submissions Mentoring engineers and strengthening Design Assurance capability across the team Why It’s Worth It Take the step from Senior Engineer to genuine Principal level influence Tackle challenging technical problems rather than simply reviewing documentation Build your career on technical depth without needing to pursue people management Work on sophisticated technology where risk, reliability and patient safety matter What You’ll Bring Significant experience developing regulated medical devices Deep technical capability across Design Assurance, Systems Engineering, V&V, Design Quality or Product Development Strong understanding of design controls, ISO13485, ISO14971 and 21 CFR 820 Experience supporting regulatory submissions and responding to regulator queries Strong regulatory judgement: you know not only whether something works technically, but whether the rationale and evidence will withstand scrutiny Confidence challenging experienced engineers and recommending alternative approaches Experience mentoring and developing technical capability in others Experience with Class II/III, implantable, connected or software-driven devices is highly regarded Culture You’ll join a technically driven, collaborative environment where Quality and Engineering work closely together. This role suits someone who asks “why?”, challenges assumptions and enjoys working through difficult problems with experienced engineers. You’ll be trusted to contribute your expertise, recommend solutions and help others develop stronger technical judgement. If you’re an experienced Principal Engineer, Design Assurance Engineer, Systems Engineer, V&V Engineer or Design Quality Engineer looking for greater technical ownership and influence, we’d like to hear from you. How to Apply Click apply or contact Eve Cooke, Senior Recruitment Consultant, on 02 8877 8722 for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits executive, permanent, contract and temporary positions at all levels across Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. Medical Affairs & Life Sciences Recruitment: Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs and 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 and Warehouse Clinical Care Recruitment: Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties and Nursing For more job opportunities, visit www.hpgconnect.com.
Benefits Broad, hands-on quality assurance role within the pharmaceutical industry. Exposure to product release, investigations, audits and continuous improvement. Contribute to quality improvement projects and global initiatives. About the company Our client is a pharmaceutical organisation bringing together specialist expertise and industry partnerships to support the supply of medicines. The business takes a collaborative approach, with teams working across functions to support its customers and partners. About the opportunity Reporting to the Quality Manager, you will support day-to-day quality assurance activities across pharmaceutical storage and distribution operations. This is a varied role that combines hands-on operational quality with opportunities to contribute to wider business improvements. You will work across product release, temperature excursions, complaints and quality investigations, while building relationships with internal teams, manufacturers and logistics providers. This opportunity would suit someone who enjoys solving problems, taking ownership of their work and collaborating across different areas of a business. Duties Review and approve product release for distribution, ensuring quality requirements are met and decisions are appropriately documented. Investigate temperature excursions and assess their impact on product quality. Manage customer complaints and returned product assessments, coordinating investigations and appropriate follow-up actions. Prepare quality reports and performance metrics, highlighting trends, risks and improvement opportunities. Support quality risk assessments, deviation investigations, root cause analysis and corrective and preventive actions (CAPAs). Maintain training records and support the delivery of GDP, GMP and procedural training. Participate in internal and external audits, support inspections and follow up on findings. Review customer and vendor approvals, maintain records and coordinate periodic reapprovals. Support change control, recall management and wider quality improvement initiatives. Skills and Experience Tertiary qualifications in a technical discipline, or relevant practical experience. Demonstrated experience within the pharmaceutical industry. Experience working within Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) quality management systems. Ability to build effective relationships across functions. Comfortable working independently and collaboratively, with the ability to adapt to changing priorities. Culture Join a quality-focused environment where collaboration and continuous improvement are shared priorities. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion. 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.
Benefits • Permanent full-time opportunity within a global med-tech company • Work across innovative medical devices and SaMD • Exposure to global quality systems, regulatory requirements and cross-functional projects About the company Join a global medical technology organisation focused on developing innovative solutions that improve patient outcomes. With an established international presence, the business operates within highly regulated healthcare environments and continues to invest in technology, quality and product development. About the opportunity An exciting opportunity is available for a QA Engineer to join this growing team in. Working as part of a global Quality Assurance function, you will support quality and compliance activities across medical devices, with a particular focus on SaMD. This is a varied position covering quality systems, complaint handling, CAPA, non-conformances, audits, risk management and design controls. You will work closely with Regulatory Affairs, Engineering, Operations, Sales and Marketing to ensure quality requirements are embedded throughout the product lifecycle. Duties • Support compliance with ISO 13485, ISO 14971 and internal Quality Management System requirements • Assist with internal, external and TGA audits and inspections • Support investigation and documentation of complaints, non-conformances and CAPAs • Assist with risk assessments and ongoing quality improvement activities • Maintain controlled documents and quality records within the QMS • Support quality and compliance training across the organisation • Assist with Design Controls activities supporting new product development projects • Partner with Engineering, Regulatory Affairs, Operations, Sales and Marketing teams • Participate in cross-functional projects to ensure quality and regulatory requirements are met • Support alignment between Australian quality activities and global policies and procedures Skills and Experience • Bachelor’s degree in Engineering, Science or a related discipline • 2 + years in Quality Assurance within the medical device industry • Working knowledge of ISO 13485 and medical device quality systems • Experience working with SaMD would be an advantage • Strong technical writing and controlled documentation experience • Exposure to design controls and product or software lifecycle processes • Strong analytical and problem-solving skills • Collaborative approach with the ability to work across multiple business functions Culture Join a collaborative and quality-focused environment where teams work closely across Quality, Regulatory, Engineering and Operations. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion. 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.
Benefits Permanent opportunity within an international pharmaceutical company Broad role across both Regulatory Affairs and Quality Assurance Work closely with local, regional and global stakeholders About the company A global pharmaceutical organisation with an established Australian presence and a strong commitment to quality, compliance and patient outcomes. About the opportunity An exciting opportunity has become available for a Senior Associate, Quality Assurance & Regulatory Affairs to join an international pharmaceutical organisation. This is a broad, hands-on position covering both Regulatory Affairs and Quality Assurance. You will support regulatory submissions and lifecycle activities across Australia and New Zealand, while also contributing to the ongoing management of the Quality Management System, GMP compliance and broader quality activities. This would suit someone with established pharmaceutical RA and/or QA experience who enjoys working across both functions and is looking for broader responsibility and exposure. Duties Prepare, submit and manage regulatory applications to the TGA and Medsafe Support regulatory activities throughout pre-submission, submission and evaluation Coordinate responses to Health Authority questions and requests Maintain regulatory dossiers, submission records and product-specific documentation Support ARTG applications, variations, renewals and ongoing product lifecycle activities Review Product Information, labels, artwork, packaging and related materials for compliance Assess regulatory impact of manufacturing, supplier, formulation, packaging and testing changes Support TGA GMP clearances, including applications, renewals and supporting documentation Maintain and support Quality Management System activities including deviations, CAPAs, change controls and complaints Support supplier qualification, vendor compliance and quality agreements Assist with product quality reviews, recalls, investigations and batch release activities Support audit, inspection and compliance readiness Skills and Experience Tertiary qualification in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, Microbiology or a related discipline 3 to 5 years' experience within pharmaceutical Regulatory Affairs or Quality Assurance Experience supporting or managing regulatory submissions Knowledge of TGA regulatory requirements, with Medsafe exposure highly regarded Good understanding of GMP requirements and pharmaceutical quality systems Experience across QMS activities such as deviations, CAPAs, change controls or complaints advantageous Experience within a pharmaceutical sponsor, manufacturer or distribution environment highly regarded Strong attention to detail and documentation skills Strong organisation and time management skills with the ability to manage competing priorities Excellent communication and stakeholder management skills Ability to work independently while collaborating effectively across teams Culture Join a collaborative and quality-focused environment where you will work across multiple areas of the business and have the opportunity to broaden your Regulatory Affairs and Quality Assurance experience. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion. 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.
