Quality Systems Engineer

About the role

Join a collaborative team at Fisher & Paykel Healthcare in Auckland, where you will play a pivotal role in maintaining and enhancing quality standards for medical device manufacturing. As a Quality Systems Engineer you will leverage your QMS and statistical expertise to support both new and existing processes.

Key responsibilities

• Collaborate with Operations, Production and Process Development to ensure compliance with quality standards.
• Provide training and guidance on the Quality Management System and statistical methods.
• Identify, propose and implement improvements to the Quality Management System.
• Support process and test method validation activities.
• Apply statistical analysis and process improvement tools to drive continuous improvement.

Required profile

• 3+ years of experience in Quality Engineering within the medical device industry.
• Tertiary qualification in Science or Engineering.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR Part 820 and MDR.
• Experience with process and test method validation.
• Strong communication, problem‑solving and relationship‑building skills.

Required skills

• ISO 13485
• ISO 14971
• 21 CFR Part 820
• MDR (Medical Device Regulation)
• Statistical analysis
• Process improvement tools (e.g., Six Sigma)
• CQE certification (preferred)

What we offer

• Inclusive and supportive work environment.
• Employee share purchase scheme and discretionary profit share.
• Generous paid parental leave and comprehensive insurance benefits.
• Performance‑based salary reviews.
• Access to state‑of‑the‑art facilities and external training programs.