Aroa Biosurgery Limited

Senior Design Quality Engineer

Aroa Biosurgery Limited  •  Auckland, NZ (Hybrid)  •  6 days ago
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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 looking for a Senior Design Quality Engineer to drive quality throughout the design control process. This role will ensure AROA’s products are safe, effective, and meet the highest standards of cGMP and regulatory compliance. As a strategic partner, you’ll collaborate with cross functional teams to implement effective QMS solutions and support market submissions. Key Responsibilities -

  • Oversee product development, ensuring compliance with design controls, risk management, usability and electrical systems standards.
  • Support multiple projects, balancing business goals and priorities with quality expectations
  • Actively engage with various stakeholder and communicate quality concerns as well as guide teams to align with AROA's QMS
  • Assess international regulatory requirements and standards and implement changes as required
  • Develop, review and approve quality systems documentation to ensure compliance and applicable regulatory requirements are met
  • Lead training and uphold quality system policies

What you’ll bring:

Minimum of 5 years’ experience working within the medical device industry or a similar regulated industry. You have previous experience in the implementation of Product Realisation per FDA’s Quality Management System Regulation and ISO 13485, and risk management per ISO 14971. You also bring:

  • Ability to manage multiple projects & prioritise tasks
  • Collaborate cross functionally across all levels of the organization while building positive relationships
  • Excellent communication skills with an ability to influence and negotiate
  • Excellent problem-solving and leadership skills

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.
  • Flexible/Hybrid Work Options – Where roles permit, enjoy flexibility to balance work and life.
  • 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.

To be considered for this opportunity you must have existing NZ working rights.

Aroa Biosurgery Limited

About Aroa Biosurgery Limited

Aroa Biosurgery is a soft-tissue regeneration company that develops, manufactures, sells and distributes medical and surgical products to improve healing in complex wounds and soft tissue reconstruction. Committed to ‘unlocking regenerative healing for everybody’, AROA’s products are developed from the Company’s proprietary AROA ECM™ Technology, a novel extracellular matrix biomaterial derived from ovine (sheep) forestomach.

The company was founded in February 2008 based on intellectual property relating to the use of a novel form of ECM isolated from forestomach extracellular matrix for use in tissue regeneration applications.

AROA is unlocking regenerative healing for everybody. AROA’s products make a meaningful impact for patients, surgeons and clinicians. AROA delivers high quality, simple to use products that significantly improve outcomes. AROA also believes its products should be widely accessible, affordable and change the standard of care for many patients.

Maori for ‘understanding’, AROA is at the forefront of understanding how biology, structural form and human factors can unlock the body’s intrinsic power to heal.

Industry
Biotech & Life Sciences
Company Size
201-500 employees
Headquarters
Mangere, NZ
Year Founded
2008
Website
aroa.com
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