Quality System Engineer - Design, Airvo

Fisher & Paykel Healthcare; Auckland; On-site; NZD 90,000 - 140,000; Full time

Benefits offered by this job

Employee share purchase scheme

Profit share

Paid Parental Leave

Life insurance

Health insurance discount

Social clubs & community groups

In-house training programs

Purchasing privileges for Fisher & Pay

School holiday programme subsidy

Banking and Insurance discounts

Free Parking

Job summary

Fisher & Paykel Healthcare in Auckland is seeking a Quality Systems Engineer to join the Design Quality Team supporting the Airvo product group. You will collaborate with product development to release newly developed devices and ensure conformance of existing products across markets.

As QSE you will lead design controls, drive QMS improvements, and act as the subject matter expert for quality discussions, enabling efficient product commercialization while upholding regulatory compliance and

Qualifications

• Minimum 3 years in Quality Engineering or related field.
• Experience in regulated manufacturing/design environments; medical devices preferred.
• Knowledge of medical device regulations and quality systems.
• Understanding of the Quality function and its impact on business.

Responsibilities

• Lead activities related to design controls and QMS implementation.
• Ensure product quality for effective commercialization and conformance.
• Provide SME support on QMS and drive continuous improvements.

Skills

Quality engineering

Regulatory knowledge

Medical devices

Communication

Education

Science/Engineering degree (industrial/biomedical/mechanical)

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.

Job description

We have an exciting opportunity for a 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 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.

About The Role

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 & Experience

We are looking for someone with:

Skills and experience required:

• A minimum of 3 years related work experience in either Quality Engineering, or in a similar technical field.
• 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 Airvo 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)

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

  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.

  Make a difference while driving your career to the next level.

  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 [e-mail]