Quality Engineer – Manufacturing

About the role

Join Fisher & Paykel Healthcare in Auckland as a Quality Engineer – Manufacturing. You will work closely with Operations, Production and Process Development teams to maintain and improve quality standards across new and existing medical device processes.

Key responsibilities

• Provide training and guidance on Quality Management System (QMS) and statistical tools.
• Identify and implement improvements to the QMS.
• Support process and test method validation activities.
• Collaborate with cross‑functional teams to resolve quality issues.
• Monitor compliance with industry standards and regulations.

Required profile

• 3+ years of Quality Engineering experience in 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 statistical and process‑improvement knowledge.
• Six Sigma or CQE certification is preferred.

Required skills

• ISO 13485
• ISO 14971
• 21 CFR Part 820
• MDR
• Statistical analysis
• Process validation
• Test method validation
• Six Sigma
• CQE

What we offer

• Employee share purchase scheme and discretionary bi‑annual profit share.
• Generous paid parental leave and comprehensive insurance coverage.
• Performance‑based salary reviews.
• In‑house training programs and external learning opportunities.
• School holiday programme subsidy.
• Free parking, green campus spaces and subsidised cafés.
• Access to state‑of‑the‑art facilities and active social clubs.