About this role
<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:10.0pt;line-height:107%">Care to find solutions</span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">Join a team of good people doing good work with intent.<strong> </strong>People like you, who care to make a difference.</span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:10.0pt;line-height:107%"> </span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:10.0pt;line-height:107%">About the opportunity</span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">Our strong focus on research and development creates a regular flow of new Fisher & Paykel Healthcare products. To enable our ongoing success, we depend on the technical expertise of our Design Quality team, who ensure our products get to market as fast as possible while meeting customer, business and international regulatory requirements. We have the opportunity to join one of our Design Quality teams at a Quality System Engineer (QSE) or Senior QSE level depening on expeirence and current level. </span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">Infant Respiratory Care & Non-invasive ventilation has a vast range of new and existing products - it’s an exciting area to be a part of! In your role you will partner with product development, clinical, marketing and regulatory teams to release newly developed products to various markets. You will also support the compliance of existing products in current and expanding markets.</span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">As QSE you will also be responsible for identifying and implementing Quality Management System (QMS) improvements, as well as being a subject matter expert for Design Controls.</span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">You will provide training, development and guidance to support the achievement of Infant Care’s business plan and ensure compliance to the QMS and regulatory requirements.</span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">Depending on the experience of the candidate, we are also open to considering candidates at a Quality Systems Engineer (QSE) level seeking a lateral move into another product group or quality department.</span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:10.0pt;line-height:107%">About you</span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">We are looking for someone with: </span></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">A minimum 3 years related experience in the medical device industry, or a similar highly regulated industry, with specific experience in Design Quality Engineering.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">A tertiary qualification in Science or Engineering.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">An understanding of quality management systems such as 21CFR820 and ISO 13485.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">Experience with product verification and validation activities.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">A strong understanding of Risk management (ISO 14971).</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">An understanding of FDA and international regulations.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">Exposure to statistical analysis techniques.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">Ideally some experience in usability engineering.</span></li> <li style="margin:0.0cm 0.0cm 8.0pt 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">A holistic approach to product development.</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">You will also have: </span></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">Excellent communication skills with the ability to influence, negotiate and challenge with respect and diplomacy.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">An ability to build relationships at all levels within the organization.</span></li> <li style="margin:0.0cm 0.0cm 8.0pt 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:10.0pt;line-height:107%">A curious and inquisitive nature and a continuous improvement mindset.</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"> </p><p><span style="font-family:Arial, Helvetica, sans-serif"><span style="font-size:10.0px"><em><span id="cke_bm_227S" style="display:none"> </span></em></span></span></p> <p><span style="font-size:12.0px"><span style="font-family:Arial, Helvetica, sans-serif"><em>Requisition ID: <em>6535</em></em> <br> <em>Posting end date: <em>15/07/2026</em><span id="cke_bm_227E" style="display:none"> </span></em></span></span></p>