Senior Quality Systems Engineer at Fisher Paykel Healthcare Limited

Howick, Auckland, New Zealand -

Full Time

Start Date

Immediate

Expiry Date

09 Aug, 26

Salary

115000.0

Posted On

11 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System (QMS), Regulatory Compliance, Continuous Improvement, Quality Engineering, Data Analysis, Risk Management, Verification and Validation, Project Management, Stakeholder Management, Corrective Actions, Nonconformance Investigation, Coaching, Problem Solving, Strategic Mindset, Cross-functional Leadership, Quality Documentation

Industry

Medical Equipment Manufacturing

Description

Care to Find Solutions 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 3 vacancies and we are looking for experienced Senior Quality Systems Engineers to drive quality excellence across our organisation. In this role, you will lead the design, improvement, and governance of our Quality Management System (QMS), ensuring products and processes meet regulatory requirements while continuously enhancing performance. You’ll play a key role in influencing cross-functional teams, solving complex quality challenges, and embedding a culture of continuous improvement. Key Responsibilities Lead the development, review, and approval of quality system documentation to ensure compliance with regulatory and internal standards Drive continuous improvement initiatives across the QMS, identifying opportunities to enhance efficiency and prevent quality issues Monitor performance against QMS objectives and implement system-wide improvements Provide expert guidance, training, and coaching to teams on quality processes and requirements Lead and support investigations into nonconformances, ensuring timely resolution and robust corrective actions Analyse production and design data to identify trends, risks, and improvement opportunities Ensure effective risk management, verification, and validation processes are in place Evaluate and report on the effectiveness of the QMS to support business objectives Collaborate and influence stakeholders across teams to successfully implement change Support customer complaint reviews and ensure adherence to defined processes About You Strong experience in quality engineering within a regulated environment Deep understanding of quality systems, compliance, and continuous improvement methodologies Proven ability to lead cross-functional initiatives and influence stakeholders Experience with quality investigations, data analysis, and process improvement tools Strong communication, coaching, and problem-solving skills Project management capability and a strategic mindset 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 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 and Medela products School holiday programme subsidy Banking and Insurance discounts Free Parking Beautiful campus with green spaces Subsidised Café’s Annual Salary Review High rates of internal promotion 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 recruit@fphcare.co.nz. This is a full-time, permanent position (40-hour week) with a salary range of $97,000 to $115,000. The role is based in our Auckland office in Highbrook Drive in East Tamaki.

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Responsibilities

Lead the design, governance, and improvement of the Quality Management System to ensure regulatory compliance and operational excellence. Drive continuous improvement initiatives and lead investigations into nonconformances to implement robust corrective actions.