Engineer - Design Quality

2 weeks ago


Auckland City, New Zealand Aroa Biosurgery Full time

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

Our mission is to be the global leader in regenerative healing, making our products and services accessible to everybody. AROA develops, manufactures, and exports innovative wound care products, improving the lives of millions around the world by unlocking extraordinary outcomes for our patients.

M ā ori for ‘understanding’, AROA is proudly New Zealand born and based. Our specialised range of soft tissue repair products utilizes our successful Endoform Extracellular Matrix (ECM) biomaterial and is sourced exclusively from NZ pasture-raised animals.

Over the past 13 years, Aroa has undergone an inspiring journey, continuously gaining momentum with each new addition to our team. Ambitious goals drive us, and it's the unique blend of our people and our dynamic culture that sets us apart. As a medium-sized business, we thrive in an environment where every individual can significantly impact the company's results and future. Aroa is a roll-up-your-sleeves kind of business, operating with agility, pace, and the entrepreneurial spirit that characterises the Kiwi way.

**What You'll Be Doing:
We have an excellent opportunity for an experienced Quality Engineer to join our dedicated and expert team.

This role presents a unique opportunity for someone with knowledge in Design Controls, ideally gained through involvement in **medical device **development projects from feasibility to commercialisation.

At this pivotal juncture in several projects, your experienced input will be instrumental. As a key member of our ambitious team, we value individuals who thrive on getting involved, possess the perseverance to see projects through, and are motivated to witness their work come to life.

As we prepare for the next phase in the Quality Department, we seek ambitious and creative individuals who can contribute to our exciting journey.

**To be considered for this opportunity, you will need:
- 2-3 years of demonstrated experience in a similar ‘quality engineering role’, preferably in Medical Device Design.
- Experience in a cGMP manufacturing environment.
- Expertise in implementing of Design Controls per 21 CFR 820 and ISO 13485.
- Experience in product verifications and validations.
- Experience in implementing the Risk Management Process per ISO 14971.
- Desired but not mandatory: Experience in IEC 62366-1, IEC 62304 and IEC 60601-1.
- Team player mindset - supporting others and providing strategies where needed.
- Passion for technology and a strong understanding of how things work.
- Practical 'Can do' attitude with a high attention to detail and excellent time management skills.
- Adaptability and willingness to engage in all aspects of the project, including department development projects.

**What we offer:



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