Quality Engineer – Design (Infant Care & NIV)

About the role

Join Fisher & Paykel Healthcare’s Design Quality team to help bring infant respiratory care and non‑invasive ventilation products to market quickly and safely. You will work across product development, clinical, marketing and regulatory functions to release new products and support existing ones.

Key responsibilities

• Partner with cross‑functional teams to release newly developed infant care products to multiple markets.
• Support compliance of existing products in current and expanding markets.
• Identify and implement Quality Management System (QMS) improvements.
• Act as a subject‑matter expert for Design Controls and provide related training.
• Ensure products meet customer, business and international regulatory requirements.

Required profile

• Minimum 3 years experience in the medical device or similarly regulated industry, focusing on Design Quality Engineering.
• Tertiary qualification in Science or Engineering.
• Understanding of quality management systems such as 21CFR820 and ISO 13485.
• Experience with product verification and validation activities.
• Strong knowledge of risk management (ISO 14971) and FDA/international regulations.

Required skills

• 21CFR820
• ISO 13485
• ISO 14971 (risk management)
• Product verification and validation
• Statistical analysis techniques
• Usability engineering (preferred)
• Design Controls expertise