Quality Systems Engineer - Design

Fisher Paykel Healthcare; San Diego (CA); On-site; USD 51,000 - 73,000; Full time

Benefits offered by this job

Employee share purchase scheme

Discretionary bi-annual profit share

Life insurance

Medical/Health insurance

Job summary

Fisher Paykel Healthcare is seeking a Quality Systems Engineer to join the Design Quality Team. The role focuses on design controls, implementing the QMS, and ensuring compliance for medical devices.

You will collaborate with product development to release new products and support existing products in markets. You will lead quality discussions, build strong cross‑functional relationships, and drive improvements with a focus on accuracy and regulatory compliance.

Qualifications

• 3+ years in Quality Engineering or a similar technical field.
• Electronics background preferred for complex devices.
• Experience in a regulated manufacturing/design environment with medical devices is advantageous.
• Knowledge of medical device regulations and electronics-focused standards preferred.
• Understanding of the Quality function and its impact on business.

Responsibilities

• Lead activities related to design controls.
• Implement and maintain the Quality Management System (QMS).
• Ensure product quality for efficient commercialization.
• Identify and implement QMS improvements; act as SME for quality questions.

Skills

Quality engineering

Regulatory knowledge

Medical devices

Electronics background

Communication skills

Education

Bachelor's degree in Science or Engineering

Tools

QMS software

Job description

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

About The Role

We have an exciting opportunity for a Quality Systems Engineer to join the Design Quality Team supporting our OSA product group based in our head office in Auckland, New Zealand. Immigration and relocation support would be provided to our preferred candidate. Working in partnership with our design and development engineering teams, you will collaborate with Product development to release newly developed products to various markets. You will also support the conformance/ compliance of existing products in their markets. Using your technical and Quality expertise you will ensure design assurance of new and existing products.

Your responsibilities include leading the activities related to the use of design controls, managing the implementation of our Quality Management System (QMS) to maintain compliance, and ensure product quality for an effective and efficient product commercialization.

As QSE you will also be responsible for identifying and implementing QMS improvements, as well as being the subject matter expert for questions and support on the QMS.

Skills and experience required:

• A minimum of 3 years related work experience in either Quality Engineering, or in a similar technical field.
• An electronics background or experience supporting complex electronic devices would be highly advantageous
• Experience in a highly regulated manufacturing and design environment, with medical devices experience highly advantageous.
• A working knowledge of the regulations that apply to the medical devices industry, understanding of electronic focused regulations is preferred
• An understanding of the Quality function and its impact on the business.

You will also have:

• An ability to build strong relationships and to work collaboratively, share knowledge and act as a guiding hand to the OSA product group regarding quality discussions.
• Excellent communication skills with the ability to share complex ideas, positively influence, negotiate and challenge with respect and diplomacy.
• Strong problem-solving ability, (both through your own independent thinking and collaboration across the business) and a strong resilience when navigating problems.
• A tertiary qualification in Science or Engineering (ideally industrial, bio-medical or mechanical)
• Employee share purchase scheme
• Discretionary bi-annual profit share
• 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
• 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, 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]