Quality Assurance Engineer

Aroa Biosurgery Limited; Auckland; On-site; NZD 90,000 - 115,000; Full time

Benefits offered by this job

Health & Wellbeing

Birthday Leave

Convenient Location

Sustainable Travel Support

Family-Friendly Benefits

Social & Team Culture

GROW TOGETHER Employee Share Plan

Career Growth & Impact

Job summary

AROA Biosurgery Limited is seeking a motivated Quality Assurance Engineer to join the Quality team in Auckland. You will oversee validation activities, qualification of equipment, risk management, and continuous improvement to ensure our wound care products meet the highest standards of compliance and safety.

In this role, you will interact with production floor processes, support design transfer, and collaborate with cross-functional teams to balance priorities and meet deadlines while

Qualifications

• Bachelor’s degree in Science, Engineering, or equivalent.
• 3+ years in Quality Assurance in the medical device, pharmaceutical, or other regulated industry.
• Strong understanding of Quality Management Systems (QMS) and cGMP.
• Working knowledge of ISO 13485 and 21 CFR Part 820.
• Hands-on experience with process validation.
• Strong technical writing and documentation review skills.
• Experience with or interest in computer system validation is desirable.

Responsibilities

• Provide quality oversight and approval of validation activities and documentation.
• Engage with production floor processes, equipment, and personnel to ensure quality standards are upheld throughout design transfer and manufacturing.
• Collaborate with cross-functional teams and 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 by identifying areas for improvement in product quality and safety.

Skills

Quality Assurance

Technical writing

Process validation

QMS / cGMP knowledge

ISO 13485 familiarity

Computer system validation

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’re looking for a motivated and detail-oriented Quality Assurance Engineer

to join our Quality team. In this critical role, you’ll provide technical quality oversight across validation, equipment qualification, risk management, and continuous improvement activities ensuring our systems, products, and processes meet the highest standards of compliance and safety. Other key responsibilities include:

• Provide quality oversight and approval of validation activities and documentation.
• Actively engage with production floor 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 you'll bring:

• Bachelor’s degree in Science, Engineering, or equivalent.
• 3+ years’ experience in Quality Assurance within the medical device, pharmaceutical, or other regulated industry.
• Strong understanding of Quality Management Systems (QMS) and cGMP.
• Working knowledge of ISO 13485 and 21 CFR Part 820.
• Hands-on experience with process validation.
• Strong technical writing skills, with experience reviewing documentation for compliance and clarity.
• Experience with or interest in computer system/software validation is desirable.

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 of 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.