Senior Quality Systems Engineer

As a Senior Quality Systems Engineer – Software you will work closely with the Software, Informatics, and ICT teams. You will apply your technical and quality expertise through the provision of appropriate training and guidance, quality reviews, and identification and resolution of quality issues. And you’ll actively engage with, and influence stakeholders to ensure the successful design of high-quality products that meet quality and regulatory requirements, contributing to their successful market acceptance. Responsibilities Your responsibilities include leading activities related to the use of design controls and managing our Quality Management System (QMS) to ensure quality is effectively and efficiently incorporated into product design. You may also be involved in identifying and supporting QMS improvements. Having a positive, practical attitude and willingness to collaborate are critical to your success. With your passion and initiative, you will lead change by influencing the organization on all levels to develop and continuously improve Software as Medical Device (SaMD), health software and computerised systems outcomes. Qualifications A tertiary qualification in Science or Engineering. 4–6 years' experience in Quality Engineering or an equivalent technical discipline, preferably with experience in software-based systems. Experience in a highly regulated design environment with medical device experience highly advantageous. Knowledge and experience with Quality Management Systems, especially focused on ISO 13485, ISO 14971, ISO 27001, and FDA's Quality System Regulations. A working knowledge of software as medical device (SaMD) and health software regulations and processing is preferred, including IEC 82304, IEC 62304, IEC 81001-5-1. Excellent communication skills with the ability to share complex ideas, positively influence, negotiate and challenge with respect and diplomacy. Project management skills and the ability to work at pace to manage competing priorities. An analytical mindset and ability to think strategically. Strong problem-solving ability, (both through your own independent thinking and collaboration across the business) and a strong resilience when navigating problems. Understanding of cloud-based software, distributed systems, and related technologies. Benefits Employee share purchase scheme Discretionary bi-annual profit share Life, Critical illness and Income Protection Insurance Discounted Health Insurance Active Social clubs & community groups In-house training programs from external providers Purchasing privileges for Fisher & Paykel Healthcare products Banking and Insurance discounts Free Parking Beautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transport choices Annual Salary Review High rates of internal promotion This is a full-time, permanent position (40 hour week) with a salary range of $97,000 to $125,000. The role is based in our Auckland office in Highbrook Drive in East Tamaki. #J-18808-Ljbffr