Engineer - Operational Quality

**Operational Quality Engineer**
- Be part of a growing kiwi success story within a supportive and fun-loving team
- On-site Gym and plenty of Free Parking
- Work in a Diverse and Inclusive Team

**About Aroa**

Here at Aroa Biosurgery we're unlocking regenerative healing for every _body. _Maori for ‘understanding’, AROA is making and creating innovative and regenerative healing products that are improving the lives of millions of people around the world. We specialise in developing, manufacturing and exporting new and exciting soft tissue regeneration products utilising our successful Endoformextracellular Matrix (ECM) biomaterial.

We have been on quite a journey here at AROA over the last 12 years and we continue to go form strength to strength each time we hire someone new to our company. We have truly ambitious goals here at AROA and we know that it's our people and the culture of the business that sets us apart from the rest. As a medium sized business, we operate in that lovely space where every person can make a huge impact on the results and future of the business.

We listed on the ASX in July 2020, (in fact, the first company to list on ASX post the COVID-19 breakout) and with an additional capital rise since then (due to investor demand), we’re primed for exponential growth in the coming years

**What you’ll be doing**

We’re looking for a full time Operational Quality Engineer to provide quality support for onsite manufacturing activities.

You will be, reviewing batch records to ensure product and process specifications are met and release commercial products in a timely manner, documenting and reviewing quality events to ensure GMP and Regulatory compliance.

You will strive to generate ideas and support continuous improvement for Aroa’s quality system and production processes.

**_Key responsibilities: _**
- Perform batch review and release activities to ensure products manufactured at Aroa are safe and effective, and manufactured in accordance with regulatory requirements and cGMP.
- Ensure and maintain compliance with regulatory requirements and cGMP for manufacturing and quality system processes.
- Assist the organisation to meet its quality and regulatory requirements through the provision of appropriate training and guidance, quality reviews, and identification and resolution of quality issues.
- Support continuous improvement for quality system processes and contribute to quality initiatives across the company.
- Generate rework plans as required to meet regulatory requirements for new market authorizations.
- Provide support to the Quality Control and Inwards Goods functions to assist with quality inspections, to identify quality issues and facilitate change accordingly.
- Perform investigations for non-conformance reports, complaints, laboratory investigations and implement and review corrective actions.

**What you’ll bring**
- A bachelors degree in Science, Engineering or equivalent
- 3-5 years’ experience working in a quality assurance role in the Medical Device, Pharmaceutical or Food industry
- Knowledge of Good Manufacturing Processes
- Quality experience in a GMP manufacturing environment
- Excellent communication and interpersonal skills with the ability to collaborate effectively with cross-functional teams
- Strong attention to detail while maintaining a wider view of business drivers

Based in Airport Oaks with easy access to the motorway, there is plenty of parking available around our offices. We also have an on-site gym, which is available for individual use, or jump in to one of our bootcamp or yoga classes.