Job Overview

We're seeking a detail-oriented Quality Assurance (QA) Associate on behalf of an innovative medical device client specializing in Class II 510(k)-exempt medical devices (including advanced user-interface health products like AVA and Mira).

In this role, you're responsible for supporting and maintaining key elements of the Quality Management System (QMS). You will ensure strict compliance with ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR frameworks, directly impacting product safety, performance, and regulatory alignment.

 

Work Schedule: 35hrs per week, Flexible within client's business hours | Australian Eastern Time

 

Key Responsibilities

• QMS Maintenance: Monitor and optimize the QMS under senior management guidance; manage document control, updating SOPs, work instructions, and quality forms.

• Design & Development Control: Support DHF (Design History File), MDF (Medical Device File), and DMR (Device Master Record) documentation updates per ISO 13485 and 21 CFR 820.30 frameworks.

• Audit Management: Assist with internal and external regulatory inspection preparations (FDA, TGA, Notified Bodies) and track corrective actions to closure.

• Production & Process Controls: Support process validation (IQ/OQ/PQ) and evaluate Engineering Change Orders (ECOs) for risk and compliance impacts.

• CAPA & Complaint Handling: Investigate nonconformances and customer complaints, conduct root-cause analyses, and analyze quality metrics for preventive actions.

• Technical Documentation: Independently draft essential QMS documents, including Instructions for Use (IFUs), Technical Files, Risk Management Review (RMS) files, and Validation protocols.

Performance Milestones & Onboarding

To ensure long-term alignment and project success, this role includes a structured onboarding schedule:

• Weeks 1–8: Complete a comprehensive, client-provided 5-session ISO 13485 QMS training program and demonstrate a clear technical understanding of product functions, manufacturing frameworks, and user interactions.

• Month 5: A sponsored opportunity to obtain a BSI ISO 13485 certification, fully funded by the client.

• Ongoing Quality Target: Maintain the QMS to ensure quarterly internal and external audits yield satisfactory results with minor non-conformities only.

 

Requirements

• Education: Bachelor’s degree in Life Sciences, Engineering, Quality Assurance, or a related technical field.

• Experience: 2–4 years of dedicated Quality Assurance experience within the medical device industry or highly regulated life science sectors.

• Regulatory Knowledge: Practical familiarity with ISO 13485:2016, FDA 21 CFR 820, and ISO 14971 risk management frameworks.

• Execution Capabilities: Proven ability to independently draft technical quality files (IFUs, V&V protocols) without reliance on external outsourcing.

• Systems: Competency in modern QMS software platforms and Microsoft Office Suite.

 

Independent Contractor Perks

• Permanent work from home

• Immediate hiring

 

Note

• Please click the "Apply" button to complete your application, including the assessment questions, technical check, and voice recording. Your hourly pay rate will be established based on your performance in the application process; submissions with all requirements fulfilled will receive priority review.