Quality Systems Engineer, Medical Devices in Auckland

Fisher Paykel Healthcare; San Diego (CA); On-site; USD 51,000 - 73,000; Full time

Benefits offered by this job

Employee share purchase scheme

Discretionary bi-annual profit share

Life insurance

Medical/Health insurance

Job summary

Fisher Paykel Healthcare is seeking a Quality Systems Engineer to join the Design Quality Team. The role focuses on design controls, implementing the QMS, and ensuring compliance for medical devices.

You will collaborate with product development to release new products and support existing products in markets. You will lead quality discussions, build strong cross‑functional relationships, and drive improvements with a focus on accuracy and regulatory compliance.

Qualifications

• 3+ years in Quality Engineering or a similar technical field.
• Electronics background preferred for complex devices.
• Experience in a regulated manufacturing/design environment with medical devices is advantageous.
• Knowledge of medical device regulations and electronics-focused standards preferred.
• Understanding of the Quality function and its impact on business.

Responsibilities

• Lead activities related to design controls.
• Implement and maintain the Quality Management System (QMS).
• Ensure product quality for efficient commercialization.
• Identify and implement QMS improvements; act as SME for quality questions.

Skills

Quality engineering

Regulatory knowledge

Medical devices

Electronics background

Communication skills

Education

Bachelor's degree in Science or Engineering

Tools

QMS software

Job description

Fisher Paykel Healthcare is seeking a Quality Systems Engineer to join the Design Quality Team. The role focuses on design controls, implementing the QMS, and ensuring compliance for medical devices.

You will collaborate with product development to release new products and support existing products in markets. You will lead quality discussions, build strong cross‑functional relationships, and drive improvements with a focus on accuracy and regulatory compliance.