About the Role Product innovation has been the cornerstone of our success since 1969, when our first prototype respiratory humidifier was developed. Today, our Respiratory Humidification (RH) products, (encompassing respiratory, infant care and anaesthetic products) continue to lead the way in delivering humidified air for our patients, ensuring the best of comfort and care. We are thrilled to offer an exciting opportunity for a Senior Design Transfer Quality Engineerto join our Design Transfer Quality Team. You will be working in partnership 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 aspire to contribute to our company's growth, we want to hear from you! In 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, outputs, process validation, design reviews, process release, and continuous improvement initiatives. Utilize your 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 verification and 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 You Required 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. Benefits Employee share purchase scheme Discretionary bi-annual Profit share Generous Paid Parental Leave 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 School holiday programme subsidy 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 Subsidised Café's Annual Salary Review High rates of internal promotion About Us Fisher & 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. We focus on nurturing a positive and inclusive culture based on trust and respect. In New Zealand, our employee-led communities, Spectra (rainbow), Manaaki (Maori) and Women in Engineering play an important role in this culture. We also have a commitment to creating a positive lasting impact on society, shown by our support of New Zealand organisations such as Diversity Works NZ, Pride Pledge and Global Women. Make a difference while driving your career to the next level and apply now! We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences. Should you require support or adjustments during our process, please let us know at ****** Requisition ID: 5106 Posting end date: 20/11/2024
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