Quality Associate (ISO 13485)

TL;DR

Quality Associate (Medical Devices): Supporting and leading the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR with an accent on design control activities, audit management, and post-market surveillance. Focus on maintaining the safety and regulatory compliance of Class II medical devices and managing CAPA processes.

Location: Remote (Brisbane, Australia)

Company

Laronix is a medical device company specializing in Class II 510(k)-exempt devices.

What you will do

• Maintain, monitor, and improve the QMS in alignment with ISO 13485 and FDA QSR requirements.
• Lead document control activities, including the distribution of SOPs and work instructions.
• Support internal and external audit preparations and serve as a point of contact for regulatory inspections.
• Manage Design History Files (DHF), Medical Device Files (MDF), and Device Master Records (DMR).
• Investigate nonconformances, customer complaints, and lead root cause analysis via CAPA processes.
• Ensure labeling and packaging meet FDA, ISO, and EU MDR requirements.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Quality, or a related field.
• 2–4 years of Quality Assurance experience in medical devices or regulated industries.
• Strong expertise in ISO 13485:2016, FDA 21 CFR 820, and ISO 14971.
• Experience with design controls, risk management, and technical documentation.
• Knowledge of Class II 510(k)-exempt device requirements.
• Ability to independently draft QMS documents, IFUs, Technical files, and V&V protocols.

Nice to have

• BSI ISO 13485 certification (company will provide funding if required).

Culture & Benefits

• Permanent work-from-home arrangement.
• Flexible scheduling within business hours.
• Immediate hiring process.