Quality Systems Engineer - Medical Devices, Auckland

Fisher Paykel Healthcare; Auckland; On-site; NZD 85,000 - 105,000; Full time

Benefits offered by this job

Employee share purchase scheme

Discretionary profit share

Life, critical illness & income-prot.

Salary reviews based on performance

In-house training programs

Free parking & campus facilities

Cafés & subsidised options

Job summary

Fisher & Paykel Healthcare is seeking a Quality Engineer – Manufacturing to join our Auckland, New Zealand site. You will work with Operations, Production and Process Development to uphold quality standards and contribute to the QMS, driving improvements with a practical, collaborative approach.

The role involves training teammates, ensuring compliance with ISO13485, ISO14971, MDR, and validating processes and tests.

Qualifications

• 3+ years of work experience in Quality Engineering in the medical device industry.
• Tertiary qualification in Science or Engineering.
• Working knowledge of ISO13485, ISO14971, 21 CFR Part 820, MDR.
• Experience with process and test method validation activities.
• Working knowledge of statistics and process improvement tools.
• Six Sigma or CQE certification is preferable.

Responsibilities

• Collaborate with Operations, Production, and Process Development teams to uphold quality standards.
• Provide training and guidance on the QMS and quality practices.
• Identify and implement improvements in the Quality Management System.

Skills

Quality engineering

Quality standards

Statistics

Six Sigma / CQE

Communication

Problem solving

Relationship building

Training & guidance

Education

Science or Engineering degree

Job description

Fisher & Paykel Healthcare is seeking a Quality Engineer – Manufacturing to join our Auckland, New Zealand site. You will work with Operations, Production and Process Development to uphold quality standards and contribute to the QMS, driving improvements with a practical, collaborative approach.

The role involves training teammates, ensuring compliance with ISO13485, ISO14971, MDR, and validating processes and tests.