Design Transfer QA Engineer – NPI & QMS, Share Scheme

Fisher Paykel Healthcare

Howick

On-site

NZD 120,000 - 160,000

Full time

3 days ago

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Benefits offered by this job

Employee share purchase scheme

Profit share

Life, critical illness & income保护

Discounted health insurance

Annual salary review

Free parking

EV charging facilities

Job summary

Fisher Paykel Healthcare is seeking a Senior Design Transfer Quality Engineer in Auckland to support NPI and manufacturing capacity, ensuring QMS compliance and robust product quality. You will collaborate with quality design, manufacturing and engineering teams to enable new processes and successful product introductions, supporting global medical device standards.

The role emphasizes regulatory knowledge (FDA/EU) and ISO 13485/14971 familiarity, with a focus on process validation, problem

Qualifications

Minimum 5 years of experience in the medical device industry or a highly regulated industry.
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 NPI and capacity increase projects.
Act as the primary QA resource for process development teams, assisting with problem-solving, reviews, validation, design reviews and continuous improvement initiatives.
Utilize knowledge of FDA and international regulations and standards to help the product group comply with quality and regulatory requirements.
Ensure released products meet specifications through effective process validation.
Design and implement continuous improvement projects for ongoing enhancement and compliance of the QMS.