OverviewJoin to apply for the Senior Design Transfer Quality Engineer role at Fisher & Paykel Healthcare.Product innovation has been the cornerstone of our success since 1969. Today, our Respiratory Humidification (RH) products, including respiratory, infant care and anaesthetic devices, continue to lead the way in delivering humidified air for patients, ensuring comfort and care.We are excited to offer an opportunity for a Senior Design Transfer Quality Engineer to join our Obstructive Sleep Apnea (OSA) Design Transfer Quality Team. You will work with our quality design, manufacturing and engineering teams to support the design and development of new manufacturing processes and to facilitate the introduction of new products to manufacturing.If you excel in a collaborative environment and want to contribute to our growth, we want to hear from you!About The RoleIn this role you will:Provide quality engineering support for New Product Introduction (NPI) and capacity increase projects.Act as the primary quality assurance resource for process development teams and other stakeholders, assisting with problem-solving, reviewing process inputs and outputs, process validation, design reviews, process release, and continuous improvement initiatives.Utilize knowledge of international regulations (FDA, EUMDR) and standards (ISO 13485, ISO 14971) to help the product group comply with quality and regulatory requirements.Ensure released products meet specifications through effective process validation, consistently aligning with the intended use.Design and implement continuous improvement projects for ongoing enhancement and compliance of the Quality Management System (QMS). About YouRequired skills and experience include:A minimum of 5 years of experience in the medical device industry or a highly regulated industry equivalent.Experience in quality engineering, design assurance, manufacturing or NPI.An understanding of FDA and international regulations and standards.A tertiary qualification in Science, Engineering or relevant discipline. Why Join Us?Supportive Team: Be part of an experienced and collaborative team.Dynamic Projects: Gain exposure to multiple and diverse projects, facilitating rapid learning and professional growth.Cross-Functional Collaboration: Work with diverse teams, stakeholders, and functions, expanding your professional network and expertise. BenefitsEmployee share purchase schemeDiscretionary bi-annual Profit shareGenerous Paid Parental LeaveLife, Critical illness and Income Protection InsuranceDiscounted Health InsuranceActive Social clubs & community groupsIn-house training programs from external providersPurchasing privileges for Fisher & Paykel Healthcare productsSchool holiday programme subsidyBanking and Insurance discountsFree ParkingBeautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transport choicesSubsidised Café’sAnnual Salary ReviewHigh rates of internal promotion About UsFisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally. We are an iconic New Zealand company with a consistent growth strategy ensuring an expanding range of innovative devices for use in respiratory care, acute care and the treatment of obstructive sleep apnea. Location & ImmigrationBased in Auckland, New Zealand. Immigration & Relocation Support will be provided to the successful candidate. Care to join us? Apply today #J-18808-Ljbffr