Quality Engineer - Design
Care to improve patient care around the world?
Join a team of good people doing good work with intent. People like you, who care to make a difference.
About the opportunity
We have an exciting opportunity for a Quality Systems Engineer to join the Design Quality Team supporting our AIRVO product group. Working in partnership with our design and development engineering teams, you will collaborate with Product development to release newly developed products to various markets. You will also support the conformance/ compliance of existing products in their markets. Using your technical and Quality expertise you will ensure design assurance of new and existing products.
Your responsibilities include leading the activities related to the use of design controls, managing the implementation of our Quality Management System (QMS) to maintain compliance, and ensure product quality for an effective and efficient product commercialization.
As QSE you will also be responsible for identifying and implementing QMS improvements, as well as being the subject matter expert for questions and support on the QMS.
About you
We are looking for someone with:
- A minimum 3 years related experience in the medical device industry, or a similar highly regulated market, with specific experience in Design Quality Engineering (NPI).
- A tertiary qualification in Science or Engineering.
- An understanding of quality management systems like 21CFR820 and ISO 13485 is preferred
- Experience with product verification and validation activities.
- A strong understanding of Risk management (ISO 14971).
- Exposure to statistical analysis techniques.
- Ideally, with some experience in design controls for mechanical/ electrical medical devices.
- Ideally some experience in reliability engineering.
- A holistic approach to product development.
You will also have:
- Excellent communication skills with the ability to influence, negotiate and challenge with respect and diplomacy.
- An ability to build relationships at all levels within the organization.
Apply now to further develop your skills and experience across the design transfer space.
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.
(select from below)
- Employee share purchase scheme
- 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 and Medela products
- School holiday programme subsidy
- Banking and Insurance discounts
- Free Parking
- Beautiful campus with green spaces
- Subsidised Café’s
- 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 organisations such as Diversity Works NZ, 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.
Requisition ID: 5431
Posting end date: 09/04/2025