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Quality Assurance

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Quality Assurance

Senior Quality Assurance Associate

  • Sydney
  • Competitive salary and benefits package

Benefits 12 month contract with potential transition to a permanent role Opportunity for professional development and internal progression Flexible working conditions, promoting work-life balance Casual, inclusive work environment About the Company Join a pioneering diagnostics company renowned for developing patented diagnostic solutions, including globally certified innovative health products. Operating across international locations, the organisation fosters a supportive, inclusive culture, driven by a dedicated team focused on global health advancements. About the Opportunity This 12-month fixed-term role is critical to maintaining and enhancing the companies Quality Management System. You will oversee batch release processes, perform internal audits, and lead compliance improvements. Working closely with the international team your role will significantly influence quality assurance, regulatory compliance, and new product development. Duties Perform detailed batch record reviews and final batch release Manage day-to-day QMS maintenance and improvements Perform internal audits and preparation for external audits Develop CAPAs, identify system deficiencies, and oversee compliance Collaborate with R&D teams on innovative product development and risk management Develop and deliver SOP and quality training materials Skills and Experience 4–7 years' QA experience in medical devices or regulated industries Proven experience conducting external and internal audits Strong skills in CAPA identification and SOP management Ability to work effectively across international teams Comfortable creating training material and presentations Culture Embraces a casual, inclusive atmosphere where employee contributions are recognized through peer nominations. Passion for improving global health outcomes is at the core of the companies mission. How to Apply Click apply or contact Davina Ocansey-Gibson, Senior Recruitment Consultant, on +61 2 8877 8712 for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits across all areas of healthcare including Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. Medical Affairs & Life Sciences: Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific Commercial: Marketing, Sales, Analytics, Government and External Affairs Operations & Infrastructure: Administration, Engineering, Finance, HR, IT, Manufacturing, Supply Chain Clinical Care: Allied Health, General Practice, Nursing, Imaging, Aged Care Visit www.hpgconnect.com for more opportunities.

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Quality Assurance

Quality Systems Specialist

  • Brisbane
  • $100 per hour + superannuation

Benefits Join a fast-growing global company specialising in innovative medical technology. Work with new, cutting-edge AI-based surgical technology. Initial 6 week contract role  Hybrid working available.   About the company This global medical technology company specialises in sports injury and post-surgical support products. With a strong presence across multiple continents, they focus on creating groundbreaking AI-driven software that assists with surgical planning and implant customisation.   About the opportunity This Quality Systems Support role offers a unique opportunity to work closely with a highly innovative team to elevate their Quality Management System (QMS) to meet global standards. The role focuses on ensuring TGA and MDR compliance and preparing for upcoming regulatory audits. As part of a growing team, you will independently assess and improve QMS processes, conduct audits, and integrate their systems into a broader global framework.   Duties Conduct a full company-wide assessment of current Quality System procedures. Identify and address compliance gaps to prepare for TGA and MDR audits. Ensure supplier controls, design documentation, and regulatory submissions are aligned with compliance standards. Independently review, update, and implement QMS processes. Provide auditing support, including mock audits and regulatory inspection readiness.   Skills and Experience Due to time constraints, it is essential that the candidate can work autonomously from week one. 8 - 10+ years in medical devices. 3–5 years’ experience with high-risk medical devices (Class IIb & III). Strong knowledge of ISO 13485, TGA regulatory frameworks, and MDR requirements. Experience in conducting audits and working with supplier quality management. Familiarity with QMS frameworks, CAPAs, non-conformances, and regulatory reporting.   How to Apply Click apply!   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.

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