Quality Engineer - Technical

Aroa Biosurgery Limited; Auckland; On-site; NZD 90,000 - 120,000; Full time

Benefits offered by this job

Health & wellbeing

Birthday leave

On-site parking

Transit subsidies

Parental leave

Team events

Share plan

Career growth

Job summary

AROA Biosurgery Limited seeks a QA Technical Engineer to oversee quality assurance across manufacturing and project activities. You will provide essential technical quality oversight for validation, equipment qualification, and risk management.

Collaborate with production teams to ensure quality standards are upheld and drive root cause analyses for QA issues. The role requires a Bachelor’s degree in science or engineering, experience in a regulated QA environment, and knowledge of QMS and cGMP.

Qualifications

• Bachelor’s degree in science or engineering.
• Experience in a regulated QA role.
• Familiarity with quality systems and cGMP.
• Knowledge of ISO 9001/13485 and 21 CFR Part 820 is preferred.
• Experience with validation or equipment qualification.
• Strong technical writing and document review skills.

Responsibilities

• Provide quality oversight and approval of validation activities and documentation.
• Actively engage with production manufacturing processes, equipment, and personnel to ensure quality standards are upheld throughout design transfer and manufacturing.
• Collaborate with cross-functional teams and effectively support multiple projects, balancing priorities to meet deadlines.
• Serve as a point of contact for QA technical issues, drive root cause analysis, and communicate quality concerns to cross-functional teams.
• Contribute to AROA’s continuous improvement efforts by identifying areas for improvement in product quality and safety.

Skills

Quality assurance

Regulatory compliance

Software validation

Technical writing

cGMP knowledge

Education

Bachelor's degree in science or engineering

Job description

At AROA, our people come to work every day with passion and ideas that fuel our business and go home knowing they have made a real difference in the lives of others.

AROA, which is Maori for ‘understanding’, is proudly New Zealand born and based. We develop, manufacture, and export innovative wound care products, improving the lives of millions around the world by unlocking extraordinary outcomes for our patients. Our mission is to be the global leader in regenerative healing, making our products and services accessible to everybody.

About the role:

We are seeking a motivated QA Technical Engineer to oversee quality assurance across manufacturing and project activities. In this role, you will provide essential technical quality oversight for validation, equipment qualification, and risk management. Other key responsibilities include:

• Provide quality oversight and approval of validation activities and documentation.
• Actively engage with production manufacturing processes, equipment, and personnel to ensure quality standards are upheld throughout design transfer and manufacturing.
• Collaborate with cross-functional teams and effectively support multiple projects, balancing priorities to meet deadlines.
• Serve as a point of contact for QA technical issues, drive root cause analysis, and communicate quality concerns to cross-functional teams.
• Contribute to AROA’s continuous improvement efforts by identifying areas for improvement in product quality and safety

What We’re Looking For:

• Bachelor’s degree in science or engineering
• Previous experience in a similar Quality role in a regulated industry
• Experience with or interest in computer system/software validation is a plus
• Good understanding of Quality Management Systems and cGMP is essential
• Some previous working knowledge of ISO 9001 or ISO 13485 and 21 CFR Part 820
• Experience in process validation or equipment qualification is recommended
• Proficiency in technical writing and reviewing documentation for compliance and clarity.

What we offer:

At AROA NZ, we value our people and make sure working with us is rewarding, both professionally and personally. Here’s what you can enjoy as part of our team:

• Health & Wellbeing – Free on-site gym and fitness classes, plus an annual paid health and wellbeing allowance.
• Birthday Leave – A paid day off to celebrate your special day!
• Convenient Location – Free carparking onsite at our Airport Oaks sites with easy motorway access.
• Sustainable Travel Support – Fareshare public transport subsidy, WorkRide program, onsite bike shed, and electric bike charging stations.
• Family-Friendly Benefits – Generous parental leave entitlements to support you and your loved ones.
• Social & Team Culture – Join a social club and enjoy team events and activities in a supportive, inclusive workplace.
• GROW TOGETHER – AROA’s Employee Share Plan an opportunity for eligible employees to share in the success and future growth AROA
• Career Growth & Impact – Be part of a mission-led company doing work that’s never been done before, with opportunities for learning, development, and real impact.