Job Title: Quality Assurance Associate – Post-Market
Location: St Leonards – Full-Time

Bilingual Required – Mandarin Strongly Preferred
Due to regional responsibilities, bilingual communication skills are essential for this position. Mandarin is strongly preferred to support collaboration across key East Asian markets.

About the Role
An exciting opportunity has become available for a dedicated and detail-focused quality assurance associate to join a leading global medical technology organisation. In this post-market surveillance role, you will support activities across the Asia-Pacific region, ensuring product safety, regulatory compliance, and continuous improvement.

Working closely with cross-functional teams, you will play a vital role in managing complaint handling, adverse event reporting, and field actions related to medical devices in a highly regulated environment.

Key Responsibilities

• Handle post-market activities including complaints, product holds, adverse event reporting, and product field actions
• Collaborate with Regulatory Affairs, Sales, Marketing, and Operations teams to ensure timely resolution of issues
• Maintain accurate and compliant records across quality systems (e.g. eQMS, CHS, Salesforce)
• Report adverse events to regulatory authorities within legislative timeframes
• Coordinate internal audits and support external audit readiness in line with ISO 13485 and local regulations
• Raise and monitor non-conformances (NCs), CAPAs, and change requests (CHGs)
• Capture and analyse quality metrics, trends, and performance indicators

What You’ll Need to Succeed

• Bilingual communication skills (Mandarin preferred)
• Experience in post-market quality assurance or regulatory affairs within the medical device or healthcare industry
• Working knowledge of ISO 13485, GDPMD, and related quality standards
• Strong attention to detail and organisational skills
• Effective communicator with the ability to work collaboratively across departments and cultures
• Proficiency in quality or ERP systems (e.g. JD Edwards, Salesforce, eQMS)
• Tertiary qualification in science, engineering, quality, logistics, or a related field (preferred)
• Certified Internal Auditor (ISO 13485) – highly regarded

What’s in it for You?

• Sydney-based role within a supportive and quality-driven team
• Exposure to international markets and regulatory environments
• Contribute to improving healthcare outcomes through quality assurance excellence
• Opportunities for professional growth and development

If you're a proactive quality professional with bilingual capability and looking to join a global leader in the medical device space, click Apply to submit your resume and Lauren from people2people will be in touch.

Operating for over 20 years in Australia, New Zealand and the United Kingdom, people2people, Edge Recruitment, and Frog Recruitment are an award-winning recruitment group and HR solutions provider. As an inclusive workforce, we welcome everyone and encourage our employees, clients, and candidates to showcase their authentic selves.

Should you require reasonable adjustments throughout the recruitment process, we encourage you to make a request by phoning the above-mentioned recruitment consultant to discuss. In response to these requests, we will collaborate closely with you to implement the appropriate adjustments.