Quality System Engineer Manager

Fisher Paykel Healthcare; Howick; On-site; NZD 140,000 - 190,000; Full time

Benefits offered by this job

Employee share purchase scheme

Profit sharing

Life & Disability Insurance

Discounted Health Insurance

In-house training programs

Free Parking

Annual salary review

Internal promotion opportunities

Job summary

Fisher & Paykel Healthcare in Auckland seeks a QSE Manager to lead a team of Quality System Engineers, ensuring design teams meet regulatory and quality standards. You will drive process improvements, apply ISO13485/14971 and FDA CFR 820 knowledge, and partner with product, operations and clinical teams to deliver compliant medical devices.

This role requires 5+ years in medical devices, a tertiary engineering qualification, and strong leadership to achieve high performance and successful market

Qualifications

• Tertiary qualification in engineering or related field with 5+ years in Medical Devices.
• QA experience in product development or new product introductions using statistical methods.
• Strong knowledge of design controls and ISO13485/ISO14971 and FDA CFR 820.

Responsibilities

• Lead a team of Quality System Engineers providing technical and quality system support for design teams.
• Drive a culture of quality and regulatory compliance across product groups.

Skills

Quality Assurance

Leadership

Regulatory Knowledge

Design Controls

Statistical Analysis

Medical Devices

Education

Engineering degree (tertiary qualification)

Job description

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Join a team of good people doinggood workwith intent.People like you, who care to make a difference.

About The Role

Our strong focus on research and development creates a regular flow of new Fisher & Paykel Healthcare products. To enable our ongoing success, we depend on the technical expertise of our Design Assurance team who ensure our products get to market as fast as possible while meeting customer, business and international regulatory requirements.

In the role of QSE Manager

You will be directly responsible for leading a team of Quality System Engineers that provide technical engineering and quality system support for the design teams within one or more of our key product groups.

About You

• You will hold a tertiary qualification in engineering or other related technical field and have a minimum 5years Medical Devices experience.
• Previous Quality Assurance experience in product development or new product introductions applying statistical and analytical techniques is required.
• You will also have extensive understanding of the technical and practical elements of design controls (and its relationship with ISO13485, ISO 14971 and FDA CFR 820) and regulatory requirements.

The real key to your success is the leadership skills you will have developed over the last 5+ years of your career and your knowledge of how to get the best out of your team.You will possess strong influencing and negotiation skills with ability to develop strong effective working relationships with the relevant areas of the business, which include product design, operations, marketing and clinical teams.

You will have strong resilience and the ability to drive change, along with a sharp and savvy approach to ensure the delivery of results.

Benefits

• Employee share purchase scheme
• Discretionary bi-annual profit share
• Life, Criticalillnessand 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
• 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
• 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, acutecareand the treatment of obstructive sleepapnea.

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 playan important rolein 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 yourequiresupport or adjustments during our process, please let us know at [e-mail]