Senior Quality System Engineer

1 week ago

Auckland, Auckland, New Zealand Fisher & Paykel Healthcare Full time

Company description:

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.

Job description:

About The Role

Our Quality and Regulatory business group is dedicated to improving patient care and outcomes. The Post-Market Surveillance team within Quality and Regulatory drives this continuous improvement by monitoring our products and services in the market, raising awareness of any quality issues and risk management activities including corrective and preventative action, health hazard evaluations and product recalls. We also manage regulatory compliance in the 120+ countries we sell our products to.

We are seeking a talented and motivated Senior Quality Systems Engineer to join our Post-Market Surveillance team to identify, design and drive quality system improvements to assist the product groups in meeting goals and objectives and regulatory requirements for the medical devices industry.

If you are passionate about data analysis, trending, cross-team collaboration, risk management and monitoring the market's pulse, this role offers a unique opportunity to make a significant impact in the medical device industry. You will work in a highly dynamic environment while constantly interacting with Product Development, Manufacturing, Regulatory and Quality teams in New Zealand and around the world.

In this role you will:

  • Collect, analyze, and interpret post-market data to identify trends, anomalies, and potential product issues to support proactive product quality improvement initiatives.
  • Collaborate cross-functionally with R&D, Regulatory Affairs, Clinical and Manufacturing teams to investigate and address potential post-market product concerns.
  • Monitor the market landscape to stay ahead of emerging trends and regulatory changes impacting our products.
  • Participate in the development of strategies for risk mitigation and continuous improvement.

About You

You will have the following skills and experience:

  • A minimum of 4yrs Quality and Regulatory experience gained in the medical devices industry.
  • A working knowledge of the FDA and international regulations that apply to the medical devices industry, i.e. EU MDR.
  • Exposure to statistical and data analysis techniques and tools.
  • Risk management experience.
  • A deep understanding of the technical aspects of Quality and strong knowledge of its impact on the business.
  • A tertiary qualification in Science or Engineering.

You will also have:

  • An ability to build strong relationships with well-developed negotiation and influencing skills.
  • Excellent communication skills with the ability to share complex ideas, positively influence, negotiate, and challenge with respect and diplomacy.
  • A positive, practical attitude, project management skills and an ability to work at pace are critical to your success.

Benefits

  • Employee share purchase scheme
  • Discretionary Bi-annual Profit share
  • Annual Salary Review
  • High rates of internal promotion
  • 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 and subsidised café's
  • Beautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transport choices

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 and apply now

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

Requisition ID: 4609
Posting end date: 12/07/2024

#J-18808-Ljbffr

  • Quality Engineer

    1 week ago

    Auckland, Auckland, New Zealand Rocket Lab USA Full time

    ENGINEERINGEngineering is at the heart of Rocket Lab. Our engineering team has a proven track record of designing and developing world-class rockets and spacecraft that are changing the way we access and use space. You'll work alongside driven, talented engineers from varied backgrounds and experience levels, all committed to the same mission. Our...

  • Senior Propulsion System Engineer

    1 week ago

    Auckland, Auckland, New Zealand Rocket Lab Full time

    Add expected salary to your profile for insights ABOUT ROCKET LABRocket Lab is a global leader in launch and space systems. The rockets and satellites we build and launch enable some of the most ambitious and vital space missions globally, supporting scientific exploration, Earth observation and missions to combat climate change, national security, and...

  • Senior Engineer

    1 week ago

    Auckland, Auckland, New Zealand LEAD Alliance Full time

    Senior Engineer - Design (Land Development) Full time Add expected salary to your profile for insights LEAD Alliance is seeking a Land Development (LD) Engineer (Design Engineering) with major project experience to work on New Zealand's largest brownfield development to transform Auckland.LEAD Alliance is an alliance laying the groundwork for the new homes...

  • Senior design engineer

    1 week ago

    Auckland, Auckland, New Zealand Hotchilly Limited Full time

    We are on the lookout for a competitive Senior design engineer to join our amazing team at HotChilly Limited in Wellington.Growing your career as a Full Time Senior design engineer is a terrific opportunity to develop competitive skills.If you are strong in planning, creativity and have the right drive for the job, then apply for the position of Senior...

  • Senior Propulsion System Engineer

    1 week ago

    Auckland, Auckland, New Zealand Rocket Lab USA Full time

    Rocket Lab is a global leader in launch and space systems. The rockets and satellites we build and launch enable some of the most ambitious and vital space missions globally, supporting scientific exploration, Earth observation and missions to combat climate change, national security, and exciting new technology demonstrations. Our Electron rocket has...

  • Senior Engineer

    1 week ago

    Auckland, Auckland, New Zealand LEAD Alliance Full time

    Senior Engineer - Design (Land Development) Full time Add expected salary to your profile for insights LEAD Alliance is seeking a Land Development (LD) Engineer (Design Engineering) with major project experience to work on New Zealand's largest brownfield development to transform Auckland.LEAD Alliance is an alliance laying the groundwork for the new homes...

  • Senior Engineer

    1 week ago

    Auckland, Auckland, New Zealand Rocket Lab USA Full time

    ABOUT ENGINEERING AT ROCKET LAB:Engineering is at the heart of Rocket Lab.Our engineering team has a proven track record of designing and developing world-class rockets and spacecraft that are changing the way we access and use space.You'll work alongside driven, talented engineers from varied backgrounds and experience levels, all committed to the same...

  • Ground Systems Engineer

    1 week ago

    Auckland, Auckland, New Zealand Rocket Lab USA Full time

    ENGINEERINGEngineering is at the heart of Rocket Lab. Our engineering team has a proven track record of designing and developing world-class rockets and spacecraft that are changing the way we access and use space. You'll work alongside driven, talented engineers from varied backgrounds and experience levels, all committed to the same mission. Our...

  • Firmware Quality Engineer

    1 week ago

    Auckland, Auckland, New Zealand Apple Inc. Full time

    Be part of the Input Device QE team, focused on testing firmware and ensuring ultra-high quality for Apple's next generation human interface devices.This includes technologies such as Multi-Touch, Heart-rate sensing, Touch ID, and other input device technologies across a variety of Apple's product linesTesting is focused on microcontroller based firmware...

  • Principal Power Systems Engineer

    1 week ago

    Auckland, Auckland, New Zealand Fluid Engineering Full time

    Fluid Recruitment is proud to exclusively partner with PBA Consulting in an exciting growth phase. We're searching for an industry leader to take the lead on their Power Systems Planning & Advisory offering.The Company Born from PBA's legacy as an industry leader in HV services, PBA Consulting was established in 2021 as a forward thinking and dynamic...

  • Supplier Quality Engineer

    1 week ago

    Auckland, Auckland, New Zealand Rocket Lab USA Full time

    ABOUT ENGINEERING AT ROCKET LAB:Engineering is at the heart of Rocket Lab. Our engineering team has a proven track record of designing and developing world-class rockets and spacecraft that are changing the way we access and use space. You'll work alongside driven, talented engineers from varied backgrounds and experience levels, all committed to the same...

  • Senior Mechatronics Engineer

    1 week ago

    Auckland, Auckland, New Zealand Steelbro Full time

    We are in search of a focused Senior Mechatronics Engineer to join our multidisciplinary team at Steelbro in Wigram, Canterbury.Growing your career as a Full time Senior Mechatronics Engineer is a promising opportunity to develop valuable skills.If you are strong in negotiation, persuasion and have the right experience for the job, then apply for the...

  • Senior Secondary System Design Engineer

    1 week ago

    Auckland, Auckland, New Zealand AECOM Full time

    We believe infrastructure creates opportunity for everyone. Whether it's improving your commute, keeping the lights on, providing access to clean water or transforming skylines, our work helps people and communities thrive.Job DescriptionLeading the change toward a sustainable and equitable futureAECOM is a leading provider of engineering, environment and...

  • Senior Software Engineer

    1 week ago

    Auckland, Auckland, New Zealand Rocket Lab Full time

    Senior Software Engineer - Operations Software Engineering - Software (Information & Communication Technology) Full time Add expected salary to your profile for insights ABOUT ROCKET LABRocket Lab is a global leader in launch and space systems. The rockets and satellites we build and launch enable some of the most ambitious and vital space missions...

  • Senior Engineer

    1 week ago

    Auckland, Auckland, New Zealand Shuttlerock Limited Full time

    We are on the lookout for a competitive Senior Engineer to join our exceptional team at Shuttlerock Limited in Nelson Central, Tasman.Growing your career as a Full time Senior Engineer is an outstanding opportunity to develop important skills.If you are strong in research, emotional intelligence and have the right aptitude for the job, then apply for the...

  • Supplier Quality Engineer

    1 week ago

    Auckland, Auckland, New Zealand MCS Group Full time

    MCS group is delighted to be exclusively recruiting an experienced Quality Engineer for the role of Lead Supplier Quality Engineer for our Lisburn based manufacturing client.This position is immediately available and offered on a contract basis.Our global client serves customers within the power and utilities industries worldwide with market leading and...

  • Senior Support Engineer

    1 week ago

    Auckland, Auckland, New Zealand Ricoh Full time

    Help Desk & IT Support (Information & Communication Technology) Lead, mentor and innovate as a Senior Support EngineerRicoh is seeking a seasoned Senior Support Engineer (L3) to be the technical lead of our Managed Delivery Team (MDT) in the Auckland CBD office. In this exciting role, you will play a crucial part in shaping the future of our IT support...

  • Senior Backend Engineer

    1 week ago

    Auckland, Auckland, New Zealand Termius Full time

    Termius is a modern SSH client built for collaboration and productivity.It organizes infrastructure knowledge and helps troubleshoot incidents quickly to reduce costly downtime.Today, our customers include over 30,000 companies, and millions of engineers use Termius to connect to their remote servers.We are looking for a Senior Backend Engineer to complement...

  • Senior Data Engineer

    1 week ago

    Auckland, Auckland, New Zealand Warner Media, LLC. Full time

    Welcome to Warner Bros. Discovery... the stuff dreams are made of.Who We Are... When we say, "the stuff dreams are made of," we're not just referring to the world of wizards, dragons and superheroes, or even to the wonders of Planet Earth. Behind WBD's vast portfolio of iconic content and beloved brands, are the storytellers bringing our characters to life,...

  • Senior Project Engineer

    1 week ago

    Auckland, Auckland, New Zealand Lynx Recruitment Full time

    Senior Project Engineer - Relocate to Queensland Are you an experienced Senior Project Engineer looking to relocate to Australia and manage major civil projects in Queensland? This could be the role for youThe CompanyOur client stands as a premier civil contractor on the Gold Coast, celebrated for its delivery of top-tier civil engineering ventures. Our...