(10/31/2025 A) Quality Systems Engineering Manager

3 days ago


Galway, Ireland Fisher & Paykel Healthcare Full time

Quality Systems Engineering Manager - Design Join to apply for the Quality Systems Engineering Manager - Design role at Fisher & Paykel Healthcare
About The Role
Our strong focus on research and development creates a regular flow of new Fisher & Paykel Healthcare products. To enable our ongoing success, we depend on the technical expertise of our Design Assurance team who ensure our products get to market as fast as possible while meeting customer, business and international regulatory requirements.
In the role of QSE Manager you will be directly responsible for leading a team of Quality System Engineers that provide technical engineering and quality system support for the design teams within one or more of our key product groups.
About You
You will hold a tertiary qualification in engineering or other related technical field and have a minimum 5 years Medical Devices experience.
Previous Quality Assurance experience in product development or new product introductions applying statistical and analytical techniques is required.
You will also have extensive understanding of the technical and practical elements of design controls (and its relationship with ISO13485, ISO 14971 and FDA CFR 820) and regulatory requirements.
The real key to your success is the leadership skills you will have developed over the last 5+ years of your career and your knowledge of how to get the best out of your team.
You will possess strong influencing and negotiation skills with ability to develop strong effective working relationships with the relevant areas of the business, which include product design, operations, marketing and clinical teams.
You will have strong resilience and the ability to drive change, along with a sharp and savvy approach to ensure the delivery of results.
Working With Us
Care to join a supportive environment? Fisher & Paykel Healthcare foster an inclusive work environment founded on our culture of care and cooperation. Here you’ll have the trust and support to generate ideas, solve problems and do your best work, while enjoying some of our perks and benefits:
Employee share purchase scheme
Discretionary bi-annual Profit share
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
Banking and Insurance discounts
Free Parking
Beautiful campus with green spaces
Annual Salary Review
High rates of internal promotion
Access to state-of-the-art facilities
About Us
Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally.
Our commitment to care unites us. Here, we’re driven to improve patient care and outcomes through inspired and world-leading healthcare solutions.
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 recruit@fphcare.co.nz.
This role is based in Auckland, New Zealand and we would require for the successful candidate to relocate to New Zealand. Immigration and Relocation support would be provided.
Requisition ID: 5383
Posting end date: 23/10/2025

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