Senior Design Transfer QA Engineer — Medical Devices (NPI)

Fisher Paykel Healthcare; Howick; On-site; NZD 96,000 - 106,000; Full time

Benefits offered by this job

Employee share purchase scheme

Profit share

Life insurance

Health insurance

Free parking

Job summary

Fisher & Paykel Healthcare is a world-leading medical device company based in New Zealand. This role focuses on quality engineering for NPI and capacity projects, ensuring process validation and design reviews align with the QMS.

You will apply FDA and international regulatory knowledge to help compliant product development and release. Cross-functional collaboration and continuous improvement are core to the role.

Qualifications

• Minimum of 5 years in medical device or highly regulated industry.
• Experience in quality engineering, design assurance, manufacturing or NPI.
• Understanding of FDA and international regulations and standards.

Responsibilities

• Provide quality engineering support for NPI and capacity increase projects.
• Act as the primary QA resource for process development teams and stakeholders.
• Assist with problem-solving, process validation, design reviews and releases.
• Drive continuous improvement initiatives within the QMS.

Skills

Quality engineering

Design assurance

NPI experience

Regulatory knowledge (FDA / ISO)

Job description

Fisher & Paykel Healthcare is a world-leading medical device company based in New Zealand. This role focuses on quality engineering for NPI and capacity projects, ensuring process validation and design reviews align with the QMS.

You will apply FDA and international regulatory knowledge to help compliant product development and release. Cross-functional collaboration and continuous improvement are core to the role.