Technical Quality Engineer

About the role

AROABIO, a New Zealand-based wound care manufacturer, is looking for a QA Technical Engineer to oversee quality assurance across manufacturing and project activities. The role provides technical quality oversight for validation, equipment qualification and risk management.

Key responsibilities

• Oversee and approve validation activities and their documentation
• Work with production, equipment and personnel to uphold quality standards during design transfer and manufacturing
• Support multiple projects with cross-functional teams and meet deadlines
• Act as the point of contact for QA technical issues, run root cause analysis and communicate quality concerns
• Identify improvements to product quality and safety to contribute to continuous improvement

Required profile

• Bachelor's degree in science or engineering
• Previous experience in a similar quality role in a regulated industry
• Good understanding of Quality Management Systems and cGMP (essential)
• Some working knowledge of ISO 9001, ISO 13485 and 21 CFR Part 820
• Experience in process validation or equipment qualification recommended

Required skills

• Interest in or experience with computer system/software validation is a plus
• Technical writing and reviewing documentation for compliance and clarity

What we offer

• Free on-site gym and fitness classes, plus an annual paid health and wellbeing allowance
• Paid birthday leave
• Free on-site carparking at the Airport Oaks site
• Fareshare public transport subsidy, WorkRide program, bike shed and e-bike charging
• Generous parental leave entitlements
• Social club, team events and an employee share plan