Quality Assurance Engineer

Posted 9 Days Ago
Be an Early Applicant
Auckland, NZL
In-Office
Mid level
Healthtech • Biotech • Manufacturing
The Role
Provides technical quality oversight for validation, equipment qualification, risk management, manufacturing, and continuous improvement in a regulated medical device environment. Reviews and approves validation documentation, supports production and design transfer, leads root cause analysis, addresses technical QA issues, and collaborates across teams to ensure compliance, product quality, and safety.
Summary Generated by Built In

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.

      Skills Required

      • Bachelor's degree in Science, Engineering, or equivalent
      • 3+ years of Quality Assurance experience in the medical device, pharmaceutical, or another 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 and experience reviewing documentation for compliance and clarity
      • Experience with or interest in computer system/software validation
      Am I A Good Fit?
      beta
      Get Personalized Job Insights.
      Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

      The Company
      247 Employees
      Year Founded: 2008

      What We Do

      Aroa Biosurgery is a soft-tissue regeneration company that develops, manufactures, and distributes medical and surgical products to improve healing in complex wounds and soft tissue reconstruction. Committed to 'unlocking regenerative healing for everybody,' the company leverages its proprietary AROA ECM™ technology—a novel extracellular matrix biomaterial derived from ovine forestomach—to create regenerative tissue substitutes that significantly improve patient outcomes.

      Similar Jobs

      Hybrid
      Auckland, NZL
      472 Employees
      In-Office
      Auckland, NZL
      13672 Employees

      Binance Logo Binance

      Quality Assurance Engineer

      Blockchain • Fintech • Software • Cryptocurrency • Metaverse
      In-Office or Remote
      24 Locations
      7696 Employees
      Hybrid
      Mangere, Auckland, NZL
      2017 Employees

      Similar Companies Hiring

      OneImaging Thumbnail
      Healthtech
      Miami, FL
      62 Employees
      Rosendin Thumbnail
      Other • Manufacturing
      San Jose, CA
      6219 Employees
      Amalgamated Sugar Thumbnail
      Food • Greentech • Agriculture • Industrial • Manufacturing
      Boise, Idaho
      768 Employees

      Sign up now Access later

      Create Free Account

      Please log in or sign up to report this job.

      Create Free Account