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Fisher & Paykel Healthcare

Quality Systems Engineer - Manufacturing

Fisher & Paykel Healthcare is hiring a Quality Systems Engineer - Manufacturing. Level rates it ; you can apply on Fisher & Paykel Healthcare.

Level's read on this job

  • Little AI ●○○○ is how Level rates this role: aI is not part of the work.
  • Tools and skills the posting cites include Iso 13485, Iso 14971 and Six Sigma.
  • Level classifies it as a senior role.
  • Level lists 11 other open roles at Fisher & Paykel Healthcare.

AI in this role

Ensure manufacturing quality standards and compliance with medical device regulations through process improvement and QMS oversight.

Iso 13485Iso 14971Six Sigma
quality-managementprocess-validationstatistical-analysis

Care to Find Solutions

Join a team of good people doing good work with intent. People like you, who care to make a difference.

In this exciting role as a Quality Engineer – Manufacturing, you'll actively collaborate with Operations, Production, and Process Development teams. Your QMS and statistical knowledge will be key in providing training and guidance to uphold quality standards for both new and existing processes. Additionally, you will contribute to identifying and implementing improvements in our Quality Management System. A practical attitude, coupled with a willingness to collaborate, is crucial for success in this role, alongside a proactive nature and results-focused approach.

Offering involvement across every function of the business and exposure to a variety of products and manufacturing processes, this full-time position at our Auckland, New Zealand site will help you develop a strong understanding of the broader business. This sets the stage for an exciting array of career advancement options within F&P.

About you

  • 3+ years of work experience in Quality Engineering in the medical device industry.
  • A tertiary qualification in Science or Engineering.
  • Working knowledge of standards and regulations (ISO13485, ISO14971, 21 CFR Part 820, MDR).
  • Experience with process and test method validation activities.
  • Working knowledge of statistics and process improvement tools.
  • Six Sigma or CQE certification is preferable

You will also have:

  • Excellent communication skills both written and verbal with the ability to share complex ideas, positively influence, negotiate, and challenge with tact and diplomacy.
  • Strong problem-solving ability, (both through your own independent thinking and collaboration across the business) and a strong resilience when navigating problems.
  • An ability to build relationships at all levels within the organization.

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
  • Generous Paid Parental Leave
  • Life, Critical illness and Income Protection Insurance & discounted Health Insurance
  • Performance based annual Salary Reviews
  • Active Social clubs & community groups
  • In-house training programs from external providers
  • School holiday programme subsidy
  • Free Parking, beautiful campus with green spaces & subsidised Café’s
  • 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.

This role is based in Aucklnad, New Zealand, successful candidate would be offered Immigration and relocation support.

Requisition ID: 6891
Posting end date: ​30/10/2026

How we rate this

Quality Systems Engineer - Manufacturing at Fisher & Paykel Healthcare rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

  1. ●●●● Builds AI80 to 100
  2. ●●●○ Works on AI60 to 79
  3. ●●○○ Uses AI40 to 59
  4. ●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.

Prepare for this job

Built from this posting and from similar jobs on Level.

Skills and AI tools this role asks for

Quality ManagementProcess ValidationStatistical AnalysisIso 13485Iso 14971Six Sigma

Questions you could be asked

  1. Tell me about a project where quality management was part of your work. What did you do?
  2. Tell me about a project where process validation was part of your work. What did you do?
  3. Tell me about a project where statistical analysis was part of your work. What did you do?
  4. What's a project where you used Iso 13485 hands-on?
  5. Walk me through how you've used Iso 14971 in your day-to-day work.

Adapt your resume

  • List these exact terms on your resume: Quality Management, Process Validation, Statistical Analysis, Iso 13485, and Iso 14971. An applicant tracking system matches the wording, not the idea.
  • Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.

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