Mirrai Careers

Design and Development Quality Manager

Aroa Biosurgery Limited

Auckland, AKL, New Zealand Temporary Posted 30+ days ago
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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: Reporting to the Director of Quality, you will lead AROA’s Design Quality team and provide strategic quality oversight across product design and development. You will work closely with R&D and other cross-functional leaders to ensure design controls, risk management, and quality-system requirements are applied pragmatically and consistently.   Key responsibilities include: * Team Leadership: Lead, coach, and build technical capability in the Design Quality team. * Product Lifecycle Quality: Provide quality oversight across product development, design transfer, and design changes. * Documentation & Risk: Oversee Design History Files (DHF), risk management, and quality planning. * R&D Partnership: Collaborate on product development, usability, software/electrical, and materials. * Compliance: Maintain effective, compliant quality systems for design, risk, and labelling. * Technical Guidance: Resolve complex technical and compliance issues while balancing business needs. * Audit Readiness: Support audit/inspection readiness and continuous process improvement.   * This is a full-time, fixed-term opportunity for approximately 14 months, providing parental leave cover.   About you You are an experienced medical-device quality leader who combines strong technical judgement with a collaborative, solutions-focused approach. You are comfortable working at both strategic and operational levels and can build confidence and quality ownership across diverse teams. You will also bring: * Bachelor’s degree in a scientific or engineering discipline. * 8+ years in quality roles within medical device manufacturing. * 5+ years leading, coaching, and developing technical teams. * Strong working knowledge of cGMP, ISO 13485, ISO 14971 and FDA 21 CFR Part 820. * Practical mastery of design controls, risk management, and product development oversight. * Excellent communication, influencing, and problem-solving skills across senior leaders and cross-functional teams. * Sound judgement and ability to make evidence-based decisions under competing priorities. * ISO/FDA audit participation experience, ISO 9001/13485 auditor certification, and knowledge of 21 CFR Part 11 and GAMP. 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 – On-site gym and fitness classes * Convenient Location – Free carparking with easy motorway access. * Sustainable Travel Support – Fareshare public transport subsidy, onsite bike shed, and electric bike charging stations. * Social & Team Culture – Join a social club and enjoy team events and activities in a supportive, inclusive workplace.

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