Quality Systems Engineer – Post Market Surveillance

About the role

Join Fisher & Paykel Healthcare’s Post‑Market Surveillance team as a Quality Systems Engineer. You will work in a fast‑moving environment, collaborating with product development, manufacturing, regulatory and quality teams worldwide to ensure the safety and performance of medical devices after they reach the market.

Key responsibilities

• Identify and resolve quality issues by continuously reviewing post‑market surveillance data and conducting risk analyses.
• Support product development teams with quality issue mitigation and process improvements.
• Assist product groups in meeting global post‑market surveillance regulatory requirements.
• Ensure that products and processes meet established quality standards and specifications.

Required profile

• Science, engineering or related tertiary degree.
• Minimum 2 years of quality and/or regulatory experience in a highly regulated environment.
• Strong understanding of FDA and international medical device regulations.
• Proven ability to communicate, negotiate and present findings to senior stakeholders.

Required skills

• Risk management
• Risk analysis
• Statistical data analysis techniques and tools
• Knowledge of FDA regulations
• Knowledge of international medical device regulations

What we offer

• Employee share purchase scheme and discretionary bi‑annual profit share.
• Annual salary review and generous paid parental leave.
• Life, critical illness and income protection insurance.
• Discounted health insurance and product purchasing privileges.
• Free parking, subsidised cafés and a green campus with EV charging.