Quality System Engineer Manager

Fisher Paykel Healthcare; New Zealand; On-site; NZD 120,000 - 160,000; Full time

Benefits offered by this job

Employee share purchase scheme

Discretionary profit share

Paid Parental Leave

Life Insurance

Disability and income protection

Discounted Health Insurance

Internal training programs

Purchasing privileges for Fisher & Pay

School holiday programme subsidy

Banking and Insurance discounts

Free Parking

Annual Salary Review

Internal promotion opportunities

Job summary

Fisher & Paykel Healthcare is seeking a QSE Manager to lead a team delivering quality system engineering and regulatory support for key product groups. You will drive design controls and ensure compliance with ISO13485, ISO14971 and FDA CFR 820 while partnering with cross-functional teams across design, operations, marketing and clinicals.

You should bring 5+ years in medical devices, strong leadership, and a track record of influencing outcomes to deliver safe, effective products.

Qualifications

• A tertiary qualification in engineering or a related technical field is required.
• Minimum 5 years’ medical devices experience is required.
• Experience applying statistical and analytical techniques in QA for product development or NPI is essential.

Responsibilities

• Lead a team of Quality System Engineers providing technical engineering and quality system support for design teams.
• Demonstrate leadership to deliver results and drive change with cross-functional stakeholders.
• Ensure compliance with ISO13485, ISO14971 and FDA CFR 820 and collaborate with product design, operations, marketing and clinical teams.

Skills

Leadership

Influencing

Negotiation

Regulatory knowledge

Statistical analysis

Analytical techniques

Quality systems

Education

Engineering or related technical field

Job description

Care to Make a Difference

Join a team of good people doing good work with 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 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.

Benefits

• Employee share purchase scheme
• Discretionary 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 products
• School holiday programme subsidy
• 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
• Subsidised Café’s
• 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, acute care and the treatment of obstructive sleep apnea.

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 [e-mail]

Requisition ID: 6937
Posting end date: 12/10/2026