Quality Assurance Engineer

TL;DR

Quality Assurance Engineer: Leading and supporting quality assurance activities across new product development and sustaining engineering programs with an accent on design controls, risk management, audit readiness, and continuous improvement of the quality system. Focus on ensuring medical device safety, quality, and compliance throughout the product lifecycle in a regulated environment.

Location: Brisbane, Australia

Company

hirify.global is an innovation-driven medical technology company developing clinically differentiated solutions to improve patient outcomes and transform workflows.

What you will do

• Serve as the QA representative on new product development and sustaining engineering projects.
• Participate in design and manufacturing reviews to ensure compliance with quality system requirements.
• Develop and maintain DFMEA/UFMEA documentation and lead risk management discussions aligned with ISO 14971.
• Review and approve design control documentation, including specifications and verification/validation records.
• Act as a subject matter expert during internal and external audits (ISO, FDA, GMP) and support audit remediation.
• Lead CAPA activities, including root cause analysis and implementation of corrective and preventive actions.

Requirements

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• 2+ years of experience in Quality Assurance or a related function in a regulated industry.
• Experience in medical device (or other highly regulated) industries.
• Working knowledge of ISO 13485 and quality system regulations.
• Strong technical writing skills and experience with controlled documentation.
• Experience with manufacturing processes including metrology, machining, grinding, cleaning, and sterilization.

Culture & Benefits

• Office-based working environment with a clean, organized, well-lit workspace.
• Low to moderate noise levels and primarily computer-based work with cross-functional collaboration.
• Occasional standing or extended desk work as required.
• Focus on continuous improvement and creating better together.