Senior Quality Systems Engineer

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 and innovative medical devices. Our Design Quality teams work closely with Product Development and cross-functional teams to ensure our products meet customer, business and international regulatory requirements.

We have X3 vacancies for Senior Quality Systems Engineers across our Design Quality teams, based at our head office in Auckland, New Zealand. 

As a Senior Quality Systems Engineer, you’ll be a trusted quality partner, working closely with Product Development, Regulatory, Clinical, Operations, Marketing and other Quality teams.

You’ll provide practical quality guidance, support quality and risk-based decision making, and help ensure our products remain safe, effective and compliant. You’ll use your experience to influence outcomes, solve complex problems and identify opportunities to strengthen quality practices and ways of working.

You’ll also play an important role in sharing your expertise, providing guidance to others and contributing to continuous improvement across the wider business.

 

About you

We’re looking for experienced Quality professionals who bring knowledge and experience across areas such as:

  • Design Quality or Quality Engineering within medical devices or another highly regulated environment
  • Design Controls and Quality Management Systems, including ISO 13485 and FDA requirements
  • Risk management, including ISO 14971
  • Product verification and validation
  • Change control and quality processes
  • Data and statistical analysis to support risk-based decision making
  • CAPA, usability engineering and international regulatory requirements
  • A relevant Science or Engineering qualification
  • Minimum 5 years of relevant industry experience

At Senior level, you’ll be comfortable operating as a trusted quality partner and subject matter expert, providing quality leadership and influencing cross-functional teams.

You’ll be a strong communicator and relationship builder who can confidently influence and constructively challenge decisions. You’ll be able to take a holistic view, balancing product quality, regulatory requirements, risk and business needs while providing guidance and development to others.

This is a full-time, permanent position (40 hour week) with a salary range of $95,000 to $125,000. The role is based in our Auckland office in Highbrook Drive in East Tamaki.

 

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 
  • Discretionary bi-annual Profit share & Annual performance-based salary Review 
  • Generous Paid Parental Leave 
  • Life, Critical illness and Income Protection Insurance 
  • Discounted Health Insurance & other Banking and Insurance discounts 
  • Active Social clubs & community groups 
  • In-house training programs from external providers & excellent career progression opportunities 
  • School holiday programme subsidy 
  • Free Parking, beautiful campus with green spaces & Subsidised Cafés 
  • 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: 6698 
Posting end date: ​27/11/2026