Senior Quality System Engineer - Design, Airvo

Fisher Paykel Healthcare; Howick; On-site; NZD 120,000 - 180,000; Full time

Benefits offered by this job

Employee share plan

Profit sharing

Life insurance

Health insurance

Job summary

Fisher & Paykel Healthcare seeks a Senior Quality Systems Engineer to support the Airvo product group. You will guide design controls, drive QMS improvements, and ensure conformance for new and existing products across markets.

You will collaborate with design, development and product teams to enable robust quality outcomes and compliant commercialization, while mentoring others in quality leadership and regulatory requirements.

Qualifications

• 5+ years of experience in Quality Engineering or a related technical field.
• Experience in a highly regulated manufacturing/design environment; medical device experience advantageous.
• Strong knowledge of regulations for medical devices; electronic-focused regulations preferred.
• Experience applying quality principles to support business objectives and product outcomes.
• Experience leading quality initiatives or complex compliance activities.

Responsibilities

• Lead activities related to design controls and quality oversight for Airvo products.
• Drive implementation and continuous improvement of the QMS to maintain compliance.
• Ensure product quality to support efficient product commercialization.
• Provide guidance and support across the organisation on QMS matters.

Skills

Quality Engineering

Regulatory Knowledge

Design Controls

Stakeholder Management

Cross-functional Leadership

Problem Solving

Biomedical

Education

Bachelors in Science/Engineering

Tools

QMS Software

Job description

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Senior Quality System Engineer - Design, Airvo

Care to Make a Difference

Join a team of good people doinggood workwith intent.People like you, who care to make a difference.

About The Role

About the Role

We have an exciting opportunity for a Senior 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 provide expert quality guidance and collaborate closely with Product Development to release newly developed products to various markets. You will also support the ongoing conformance and compliance of existing products in their markets. Using your technical and quality expertise, you will ensure robust design assurance for both new and existing products.

Your responsibilities includeleading and providing technical oversight for activities related to the use of design controls, driving the implementation and continuous improvement of our Quality Management System (QMS) to maintain compliance, and ensuring product quality to support effective and efficient product commercialisation.

As a Senior Quality Systems Engineer, you will also be responsible for identifying and implementing QMS improvements, acting as a recognised subject matter expert for quality systems, and providing guidance and support across the organisation on QMS-related matters.

Skills & Experience

We are looking for someone with:

Skills and experience required:

• A minimum of5 years' related work experience in Quality Engineering or a similar technical field.
• Experience in a highly regulated manufacturing and design environment, with medical device experience highly advantageous.
• Strong working knowledge of the regulations that apply to the medical devices industry, with an understanding of electronic-focused regulations preferred.
• Demonstrated experience applying quality principles to support business objectives and product outcomes.
• Experience leading quality initiatives, projects, or complex compliance activities.

You will also have:

• The ability to build strong relationships, influence stakeholders, and work collaboratively across teams, sharing knowledge and providing quality leadership to the Airvo product group.
• Excellent communication skills with the ability to communicate complex concepts, positively influence, negotiate, and challenge constructively with respect and diplomacy.
• Strong problem-solving capability, combining independent judgement with cross-functional collaboration to address complex issues.
• Resilience and the ability to navigate ambiguity while driving quality-focused outcomes.
• A tertiary qualification in Science or Engineering (ideally Industrial, Biomedical or Mechanical).

Employee share purchase scheme

Discretionary bi-annual profit share

Life, Criticalillnessand Income Protection Insurance

Discounted Health Insurance

Active Social clubs & community groups

In-house training programs from external providers

Purchasing privileges for Fisher & Paykel Healthcare products

Banking and Insurance discounts

Free Parking

Beautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transport choices

Annual Salary Review

High rates of internal promotion

About Us

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally. We are an iconic New Zealand company with a consistent growth strategy ensuring an expanding range of innovative devices for use in respiratory care, acutecareand the treatment of obstructive sleepapnea.

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 playan important rolein 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 requiresupport or adjustments during our process, please let us know [e-mail]

Requisition ID: 6801
Posting end date: 23/09/2026