Fisher & Paykel Healthcare
Quality Engineer/Senior Quality Engineer - Design (Infant Care & NIV)
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
This role is based in Auckland, New Zealand and the suitable candidate would be offered Immigration and Relocation support.
Care to find solutions
Join a team of good people doing good work with intent. People like you, who care to make a difference.
About The Opportunity
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 Quality team, who ensure our products get to market as fast as possible while meeting customer, business and international regulatory requirements. We have the opportunity to join one of our Design Quality teams at a Quality System Engineer (QSE) or Senior QSE level depending on experience and current level.
Infant Respiratory Care & Non-invasive ventilation has a vast range of new and existing products - it’s an exciting area to be a part of! In your role you will partner with product development, clinical, marketing and regulatory teams to release newly developed products to various markets. You will also support the compliance of existing products in current and expanding markets.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
As QSE you will also be responsible for identifying and implementing Quality Management System (QMS) improvements, as well as being a subject matter expert for Design Controls.
You will provide training, development and guidance to support the achievement of Infant Care’s business plan and ensure compliance to the QMS and regulatory requirements.
Depending on the experience of the candidate, we are also open to considering candidates at a Quality Systems Engineer (QSE) level seeking a lateral move into another product group or quality department.
About You
We are looking for someone with:
- A minimum 3 years related experience in the medical device industry, or a similar highly regulated industry, with specific experience in Design Quality Engineering.
- A tertiary qualification in Science or Engineering.
- An understanding of quality management systems such as 21CFR820 and ISO 13485.
- Experience with product verification and validation activities.
- A strong understanding of Risk management (ISO 14971).
- An understanding of FDA and international regulations.
- Exposure to statistical analysis techniques.
- Ideally some experience in usability engineering.
- A holistic approach to product development.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
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.
- A curious and inquisitive nature and a continuous improvement mindset.
Requisition ID: 6535
Posting end date: 15/07/2026
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Skills