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.
Infant Respiratory Care has a vast range of new and existing Infant Care 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.
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.
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.
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.
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
Requisition ID: 5599
Posting end date: 18/06/2025
Report job
