Quality Systems Engineering Manager - Med Devices

Fisher Paykel Healthcare

Howick

On-site

NZD 140,000 - 190,000

Full time

7 days ago

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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

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

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