Associate Manager

**Associate Manager - QA Technical**
- Be part of a growing kiwi success story within a supportive and fun-loving team
- On-site Gym and plenty of Free Parking
- Have your birthday off

**About Aroa
Here at Aroa Biosurgery we're unlocking regenerative healing for every _body. _M ā ori 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 Endoform extracellular Matrix (ECM) biomaterial.

We have been on quite a journey here at AROA over the last 12 years and we continue to go from strength to strength each time we hire someone new. We have truly ambitious goals, 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 raise 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 Associate Manager to join our Quality Assurance team.

This role is responsible for ensuring quality and compliance in activities such as qualification, validation, calibration, and maintenance. They collaborate with cross-functional teams, review validation strategies and documentation, and provide quality oversight for validation and project activities. This role leads the QA Technical team, supervises quality staff, and drives continuous improvement efforts to maintain high-quality and safety standards for AROA products.

**Key responsibilities**:

- Provide support for quality relevant projects, raising relevant quality issues, providing input in decisions, and assisting in the planning of validation activities.
- Develop, review and approve qualification and validation strategies, approaches and documentation for manufacturing processes, equipment, test methods, and computer systems.
- Review and approve equipment calibration and maintenance records to ensure accuracy, completeness of information and adherence to schedules.
- Assist the organisation with meeting its requirements through the provision of appropriate training and identification and resolution of quality issues.
- Work closely with cross-functional teams to ensure that quality standards are maintained throughout design transfer and manufacturing processes
- Contribute to AROA’s efforts to continuously improve product quality and safety, including identifying areas for improvement and implementing solutions to address these.
- Develop and lead the QA Technical team and quality planning activities in accordance with strategic goals.

**What you’ll bring**
- A tertiary qualification in Science or Engineering
- Further study in the field of Quality is advantageous.
- Minimum 5 years’ experience in quality assurance in the medical device or pharmaceutical manufacturing industry
- Knowledge of GMP, ISO 13485 and 21 CFR Part 820 requirements essential, knowledge of 21 CFR Part 11 and GAMP advantageous
- Strong technical writing ability
- 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

You will be a creative and timely problem-solver, making evidence-based decisions. You’ll also have a sound leadership background with the ability to delegate effectively, leverage juniors and give clear instructions, and provide coaching and professional development to all reports

Based in Airport Oaks with easy access to the motorway, there is plenty of parking available around our offices. Our teams are flexible, with a mix of being in office + working from home. We also have an on-site gym, which is available for individual use, or jump in to one of our bootcamp or yoga classes.