Quality Systems Engineer – Medical Devices (NZ)

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…

Job summary

Fisher & Paykel Healthcare in Auckland, New Zealand, is seeking a Quality Engineer – Manufacturing to collaborate with Operations, Production and Process Development to uphold quality standards across new and existing processes.

You will apply your QMS and statistical knowledge, participate in process and test method validation, and contribute to improvements within the Quality Management System, while benefiting from diverse products and growth opportunities.

Qualifications

• 3+ years in Quality Engineering in medical devices.
• Degree in Science or Engineering.
• Knowledge of ISO13485/ISO14971/21 CFR 820/MDR and associated quality systems.

Responsibilities

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

Skills

Quality engineering

Statistics

Process validation

Regulatory standards

Six Sigma / CQE

Communication

Relationship building

Education

Science or Engineering degree

Job description

Fisher & Paykel Healthcare in Auckland, New Zealand, is seeking a Quality Engineer – Manufacturing to collaborate with Operations, Production and Process Development to uphold quality standards across new and existing processes.

You will apply your QMS and statistical knowledge, participate in process and test method validation, and contribute to improvements within the Quality Management System, while benefiting from diverse products and growth opportunities.