Quality Assurance Associate (Medtech)

Location: Old Toongabbie, New South Wales, Australia; onsite at the manufacturing facility

Company

Healthcare company focused on improving healthcare delivery and developing products and services that help save and sustain lives.

What you will do

• Review batch documentation for cGMP compliance before batches are released to market.
• Coordinate customer complaint reviews, investigations, trend analysis, and timely closure.
• Analyze complaints, waste, and scrap trends with Manufacturing teams to support reduction initiatives.
• Lead or support root cause analysis for customer complaints, deviations, NCRs, and MPIs.
• Manage Manufacturing Non-Conformance Reports and Manufacturing Process Improvements, including associated CAPAs.
• Provide quality inputs for monthly indicators, management reviews, annual product reviews, and batch release activities.

Requirements

• Tertiary degree in Pharmacy, Science, Engineering, or a related field.
• Experience in sterile manufacturing and/or quality assurance processes.
• Strong understanding of regulatory requirements and quality standards.
• Strong attention to detail, analytical ability, communication, and collaboration skills.
• Proficiency with quality management software and tools.
• Ability to meet deadlines and manage multiple tasks simultaneously.

Culture & Benefits

• Work in a highly regulated manufacturing environment focused on product quality and compliance.
• Collaborate with Quality and Manufacturing teams on continuous improvement.
• Join a workplace culture centered on courage, trust, collaboration, ownership, and accountability.
• Reasonable accommodations are available for candidates with disabilities during the recruitment process.