Senior Quality System Engineer - Design, Airvo

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

Benefits offered by this job

Employee share purchase scheme

Discretionary profit share

Generous parental leave

Life, illness & income protection

Job summary

Fisher & Paykel Healthcare seeks a Senior Quality Systems Engineer to join the Design Quality Team supporting the Airvo product group. You will provide expert quality guidance, collaborate with Product Development and release new products to markets while maintaining conformance of existing products.

You will lead activities related to design controls, drive QMS improvements, and act as a SME for quality systems, enabling robust design assurance and compliant product commercialization.

Qualifications

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

Responsibilities

• Provide expert quality guidance to the design and development teams.
• Lead design controls and ensure robust design assurance for new and existing products.
• Drive the implementation and continuous improvement of the Quality Management System (QMS).
• Ensure product quality to support efficient product commercialization across markets.
• Identify and implement QMS improvements and provide guidance across the organisation.

Skills

Quality engineering

Regulatory compliance

Medical devices

Quality management systems

Leadership

Communication

Problem solving

Cross-functional collaboration

Education

Science or Engineering degree

Job description

Senior Quality System Engineer - Design, Airvo

Fisher & Paykel Healthcare – Auckland, North Island

Driven by a strong sense of purpose, we are working to improve patient care and outcomes through inspired and world-leading healthcare solutions.

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

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 include leading 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:

• A minimum of 5 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).

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*******@fphcare.co.nz