Join to apply for the Senior Design Transfer Quality Engineer role at Fisher & Paykel HealthcareOverviewWe are thrilled to offer an exciting opportunity for a Senior Design Transfer Quality Engineer to join our Obstructive Sleep Apnea (OSA) Design Transfer Quality Team. You will work in partnership with quality, design, manufacturing, and engineering teams to support the design and development of new manufacturing processes and facilitate the introduction of new products to manufacturing.ResponsibilitiesProvide 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 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 You / QualificationsA 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 a 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 promotionAbout 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.Care to join us? Apply todayWe focus on nurturing a positive and inclusive culture based on trust and respect. In New Zealand, our employee-led communities, Spectra (rainbow), Manaaki (Māori) 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 organizations such as Te Uru Tangata – Centre for Workplace Inclusion, Pride Pledge and Global Women.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 recruit@fphcare.co.nz.Based in Auckland, New Zealand. Immigration & Relocation support will be provided to the successful candidate.
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