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Senior Design Transfer Quality Engineer / DTQE

Senior Design Transfer Quality Engineer / DTQE

Fisher & Paykel HealthcareAuckland, Auckland, New Zealand
22 hours ago
Job description

Senior Design Transfer Quality Engineer / DTQE

Join to apply for the Senior Design Transfer Quality Engineer / DTQE role at Fisher & Paykel Healthcare

Overview

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.

Responsibilities

  • 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 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 / Qualifications

  • 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.

    Care to join us? Apply today

    We 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

    Depending on the experience of the candidate, we have the flexibility to consider candidates at the Senior Design Transfer Quality Engineer as well as DTQE.

    If you excel in a collaborative environment and aspire to contribute to our company's growth, we want to hear from you!

    Requisition ID : 5934

    Posting end date : 11 / 09 / 2025

    Seniority level

  • Mid-Senior level

    • Employment type

  • Full-time

    • Job function

  • Engineering, Manufacturing, and Quality Assurance
  • Industries : Biotechnology Research, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing

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