Quality Systems Engineer - Medical Devices, Manufacturing

Fisher Paykel Healthcare; Auckland; On-site; NZD 90,000 - 120,000; Full time

Benefits offered by this job

Employee share purchase scheme

Discretionary Bi-annual Profit share

Generous Paid Parental Leave

Life, Critical illness and Income PRO

Performance based annual SalaryReviews

Job summary

Fisher & Paykel Healthcare is seeking a Quality Engineer – Manufacturing for our Auckland, New Zealand site. You will collaborate with Operations, Production and Process Development to uphold quality standards across new and existing processes, using your QMS and statistical knowledge to train teams and drive improvements.

In this role you will contribute to identifying enhancements in our Quality Management System and work with cross-functional groups to ensure compliant, reliable products for

Qualifications

• 3+ years of experience in Quality Engineering in the medical device industry.
• Tertiary qualification in Science or Engineering.
• Experience with standards and regulations (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 preferable.

Skills

Quality engineering

Statistics

Process improvement

Regulatory standards

Education

Bachelor's degree in science or engineering

Job description

Fisher & Paykel Healthcare is seeking a Quality Engineer – Manufacturing for our Auckland, New Zealand site. You will collaborate with Operations, Production and Process Development to uphold quality standards across new and existing processes, using your QMS and statistical knowledge to train teams and drive improvements.

In this role you will contribute to identifying enhancements in our Quality Management System and work with cross-functional groups to ensure compliant, reliable products for