Quality Systems Engineer

Fisher & Paykel Healthcare; Auckland; On-site; NZD 90,000 - 120,000; Full time

Benefits offered by this job

Employee share scheme

Profit sharing

Parental leave

Life and income protection insurance

Discounted health insurance

Free parking

Job summary

Fisher & Paykel Healthcare in Auckland is seeking a Quality System Engineer (QSE) to join our Design Quality team. You will help release new infant respiratory care and non-invasive ventilation products to global markets by ensuring products meet regulatory and customer requirements.

The role requires strong knowledge of QMS (ISO 13485, 21 CFR 820) and risk management (ISO 14971), plus product verification/validation.

Qualifications

• Minimum 3 years’ experience in medical device or highly regulated industry, with Design Quality Engineering experience.
• Tertiary qualification in Science or Engineering.
• Understanding of quality management systems such as 21CFR820 and ISO 13485.
• Experience with product verification and validation activities.
• Strong knowledge of ISO 14971 risk management.
• Familiarity with FDA and international regulations.
• Exposure to statistical analysis techniques.

Responsibilities

• Release newly developed products to global markets ensuring compliance with QMS and regulatory requirements.
• Partner with product development, clinical, marketing and regulatory teams.
• Identify and implement Quality Management System (QMS) improvements.
• Provide training, development and guidance to support business plans and regulatory compliance.

Skills

Quality systems

Design Controls

Regulatory compliance

Risk management

Statistical analysis

Usability engineering

Cross-functional collaboration

Communication skills

Education

Science or Engineering degree

Job description

Job description

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 Fisher & Paykel Healthcare products. To enable our ongoing success, we depend on the technical expertise of our Design Quality team, who ensure our products get to market as fast as possible while meeting customer, business and international regulatory requirements. We have the opportunity to join one of our Design Quality teams at a Quality System Engineer (QSE).

Infant Respiratory Care & Non-invasive ventilation has a vast range of new and existing products - it’s an exciting area to be a part of! In your role you will partner with product development, clinical, marketing and regulatory teams to release newly developed products to various markets. You will also support the compliance of existing products in current and expanding markets.

As QSE you will also be responsible for identifying and implementing Quality Management System (QMS) improvements, as well as being a subject matter expert for Design Controls.

You will provide training, development and guidance to support the achievement of Infant Care’s business plan and ensure compliance to the QMS and regulatory requirements.

About You

We are looking for someone with:

• A minimum 3 years related experience in the medical device industry, or a similar highly regulated industry, with specific experience in Design Quality Engineering.
• A tertiary qualification in Science or Engineering.
• An understanding of quality management systems such as 21CFR820 and ISO 13485.
• Experience with product verification and validation activities.
• A strong understanding of Risk management (ISO 14971).
• An understanding of FDA and international regulations.
• Exposure to statistical analysis techniques.
• Ideally some experience in usability engineering.
• A holistic approach to product development.

You will also have:

• Excellent communication skills with the ability to influence, negotiate and challenge with respect and diplomacy.
• An ability to build relationships at all levels within the organization.
• A curious and inquisitive nature and a continuous improvement mindset.

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
• 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 and Medela products
• School holiday programme subsidy
• Banking and Insurance discounts
• Free Parking
• Beautiful campus with green spaces
• Subsidised Café’s
• Annual Salary Review
• High rates of internal promotion
• Access to state-of-the‑art facilities

If this sounds like you, we would love to hear from you!

Requisition ID: 6778

Posting end date: 27/08/2026