Quality Assurance

Sydney I $40.00 - $42.00 Hourly I Full Time

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Quality Assurance

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.