QSE Manager - Design

Fisher Paykel Healthcare; Howick; On-site; NZD 127,000 - 140,000; Full time

Benefits offered by this job

Employee share plan

Profit sharing

Life and income protection

Health insurance discount

Social clubs

Training programs

Purchasing privileges

Banking discounts

Free parking

EV charging facility

Salary review

Internal promotion

Job summary

Fisher & Paykel Healthcare, a world leader in medical devices, is seeking a QSE Manager to lead the Quality System Engineers and ensure design teams meet regulatory requirements.

The role focuses on providing technical engineering and quality system support for multiple product groups, with a strong emphasis on leadership and change management within a fast-paced R&D environment in Auckland.

Qualifications

• Engineering degree or related technical field.
• Minimum 5 years of medical devices experience.
• Strong leadership experience.
• Deep understanding of design controls and regulatory requirements (ISO13485, ISO14971, FDA CFR 820).

Responsibilities

• Lead a team of Quality System Engineers providing technical engineering and quality system support for design teams.
• Ensure compliance with regulatory requirements and standards.
• Collaborate with product design, operations, marketing and clinical teams to drive quality across development stages.
• Drive continuous improvement and change management within the QA and design assurance functions.

Skills

People leadership

Quality Assurance

Design controls

Medical devices

Regulatory knowledge

Education

Engineering degree

Job description

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

About The Role

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 Assurance team who ensure our products get to market as fast as possible while meeting customer, business and international regulatory requirements.

In the role of QSE Manager

you will be directly responsible for leading a team of Quality System Engineers that provide technical engineering and quality system support for the design teams within one or more of our key product groups.

About You

• You will hold a tertiary qualification in engineering or other related technical field and have a minimum 5years Medical Devices experience.
• Previous people leadership experience
• Previous Quality Assurance experience in product development or new product introductions applying statistical and analytical techniques is required.
• You will also have extensive understanding of the technical and practical elements of design controls (and its relationship with ISO13485, ISO 14971 and FDA CFR 820) and regulatory requirements.

The real key to your success is the leadership skills you will have developed over the last 5+ years of your career and your knowledge of how to get the best out of your team.You will possess strong influencing and negotiation skills with ability to develop strong effective working relationships with the relevant areas of the business, which include product design, operations, marketing and clinical teams.

You will have strong resilience and the ability to drive change, along with a sharp and savvy approach to ensure the delivery of results.

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 at [e-mail]

This is a full-time, permanent position (40 hour week) with a salary range of $127,000 to $140,000. The role is based in our Auckland office in Highbrook Drive in East Tamaki.

Requisition ID: 6995
Posting end date: 07/11/2026