Quality Systems Engineer

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Fisher & Paykel Healthcare seeks a Quality Systems Engineer - Manufacturing to collaborate with Operations and Process Development, using QMS and statistics to train teams and uphold quality while driving improvements across new and existing processes. This onsite Auckland role offers product exposure. Requirements include 3+ years in quality engineering in the medical device field, a Science or Engineering degree, and knowledge of ISO 13485, ISO 14971, 21 CFR 820 and MDR, plus experience with process and test method validation and statistics; Six Sigma or CQE is preferred. Strong communication and relationship building are essential. Apply by tailoring your CV to regulatory experience and improvements; email [email protected] for adjustments.

Care to Find Solutions

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

In this exciting role as a Quality Engineer – Manufacturing, you'll actively collaborate with Operations, Production, and Process Development teams. Your QMS and statistical knowledge will be key in providing training and guidance to uphold quality standards for both new and existing processes. Additionally, you will contribute to identifying and implementing improvements in our Quality Management System. A practical attitude, coupled with a willingness to collaborate, is crucial for success in this role, alongside a proactive nature and results-focused approach.

Offering involvement across every function of the business and exposure to a variety of products and manufacturing processes, this full-time position at our Auckland, New Zealand site will help you develop a strong understanding of the broader business. This sets the stage for an exciting array of career advancement options within F&P.

About you

• 3+ years of work experience in Quality Engineering in the medical device industry.
• A tertiary qualification in Science or Engineering.
• Working knowledge of standards and regulations (ISO13485, ISO14971, 21 CFR Part 820, MDR). 
• Experience with process and test method validation activities.
• Working knowledge of statistics and process improvement tools.
• Six Sigma or CQE certification is preferable 

You will also have: 

• Excellent communication skills both written and verbal with the ability to share complex ideas, positively influence, negotiate, and challenge with tact and diplomacy. 
• Strong problem-solving ability, (both through your own independent thinking and collaboration across the business) and a strong resilience when navigating problems.
• An ability to build relationships at all levels within the organization.

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
• Discretionary Bi-annual Profit share
• Generous Paid Parental Leave
• Life, Critical illness and Income Protection Insurance & discounted Health Insurance
• Performance based annual Salary Reviews
• Active Social clubs & community groups
• In-house training programs from external providers
• School holiday programme subsidy
• Free Parking, beautiful campus with green spaces & subsidised Café’s

• Access to state-of-the-art facilities

About Us

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally.

Our commitment to care unites us. Here, we’re driven to improve patient care and outcomes through inspired and world-leading healthcare solutions.

Care to join us? Apply today

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 [email protected].

This is a full-time, permanent position (40 hour week) with a salary range of $95,000 - $105,000. The role is based in our Auckland office in Highbrook Drive in East Tamaki.