NPI Quality Engineer – Medical Devices (Design Transfer)

Fisher & Paykel Healthcare

Auckland

On-site

NZD 85,000 - 95,000

Full time

14 days+

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Benefits offered by this job

Employee share purchase scheme

Profit sharing (bi-annual)

Life, CI & income protection insurance

Discounted health insurance

Free parking

Annual salary review

Internal promotions

Job summary

Fisher & Paykel Healthcare is seeking a Quality Engineer in Auckland to support the Design Transfer Quality Team. You will collaborate with quality design, manufacturing and engineering to develop new manufacturing processes and introduce new products to production.

The role requires 2+ years in a regulated medical device environment, knowledge of FDA and ISO standards, and a degree in Science or Engineering. Competitive benefits and a dynamic campus environment await.

Qualifications

Minimum 2 years in the medical device industry or a highly regulated field.
Experience in quality engineering, design assurance, manufacturing or NPI.
Understanding of FDA and international regulations and standards.
Tertiary qualification in Science, Engineering or relevant discipline.

Responsibilities

Provide quality engineering support for New Product Introduction (NPI) and capacity increase projects.
Act as the primary QA resource for process development teams, assisting with problem-solving and reviews.
Ensure compliance with quality and regulatory requirements (FDA, ISO 13485, ISO 14971).
Design and implement continuous improvement projects for the QMS.