Benefits

• Join a fast-growing global company specialising in innovative medical technology.
• Work with new, cutting-edge AI-based surgical technology.
• 14 to 16 week contract role with a competitive salary.
• 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 or contact Alex Gooding, Senior Recruitment Consultant on 02 8877 8775 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.