Senior/Intermediate NPI Quality Engineer

Fisher & Paykel Healthcare
Massachusetts, US
On-site

Job Description

Location: Auckland, New Zealand

Relocation Support for Individuals & Families:

Work Visa's & Child Visa's

Relocation Flights + Additional Baggage

Temporary Accommodation

Rental Car

Care to make a differenc

eJoin a team of good people doing good work with intent. People like you, who care to make a difference

.

About the Rol

eProduct 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 multiple opportunities for a Senior Design Transfer Quality Engineer to join our Obstructive Sleep Apnea (OSA) & Airvo 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 manufacturin

g.

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

ou

In this role you w

ill:Provide quality engineering support for New Product Introduction (NPI) and capacity increase proje

cts.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 initiati

ves.Utilize your knowledge of international regulations (FDA, EUMDR) and standards (ISO 13485, ISO 14971) to help the product group comply with quality and regulatory requireme

nts.Apply analytical thinking and intellectual curiosity to ensure every product meets specifications and intended use through rigorous process verification and validat

ion.Design and implement continuous improvement projects for ongoing enhancement and compliance of the Quality Management System (Q

MS).

Abou

t YouRequired skills and experience inc

lude:A minimum of 5 years of experience in the medical device industry or a highly regulated industry equiva

lent.Experience in quality engineering, design assurance, manufacturing or

NPI.An understanding of FDA and international regulations and stand

ards.A tertiary qualification in Science, Engineering or relevant discip

line.

Why J

oin Us?Supportive Team: Be part of an experienced and collaborativ

e 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 exp

ertise.

BenefitsEmployee share purcha

se schemeDiscretionary bi-annual Pro

fit shareGenerous Paid Paren

tal LeaveLife, Critical illness and Income Protection

InsuranceDiscounted Health

InsuranceActive Social clubs & communi

ty groupsIn-house training programs from external

providersPurchasing privileges for Fisher & Paykel Healthcare

productsSchool holiday programm

e subsidyBanking and Insurance

discountsFre

e ParkingBeautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transpor

t choicesSubsidis

ed Café’sAnnual Sala

ry ReviewHigh rates of internal

promotio

n

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 sl

eep apnea.

Care to join us?

Apply today

Skills & Requirements

Technical Skills

Quality engineeringDesign assuranceManufacturingNpiFdaEumdIso 13485Iso 14971Problem-solvingCommunicationMedical deviceRegulatory compliance

Employment Type

FULL TIME

Level

senior

Posted

5/5/2026

Apply Now

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