Quality Systems Engineer - QMS & Design Controls

Fisher & Paykel Healthcare; Auckland; On-site; NZD 90,000 - 120,000; Full time

Benefits offered by this job

Employee share scheme

Profit sharing

Parental leave

Life and income protection insurance

Discounted health insurance

Free parking

Job summary

Fisher & Paykel Healthcare in Auckland is seeking a Quality System Engineer (QSE) to join our Design Quality team. You will help release new infant respiratory care and non-invasive ventilation products to global markets by ensuring products meet regulatory and customer requirements.

The role requires strong knowledge of QMS (ISO 13485, 21 CFR 820) and risk management (ISO 14971), plus product verification/validation.

Qualifications

• Minimum 3 years’ experience in medical device or highly regulated industry, with Design Quality Engineering experience.
• 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 ISO 14971 risk management.
• Familiarity with FDA and international regulations.
• Exposure to statistical analysis techniques.

Responsibilities

• Release newly developed products to global markets ensuring compliance with QMS and regulatory requirements.
• Partner with product development, clinical, marketing and regulatory teams.
• Identify and implement Quality Management System (QMS) improvements.
• Provide training, development and guidance to support business plans and regulatory compliance.

Skills

Quality systems

Design Controls

Regulatory compliance

Risk management

Statistical analysis

Usability engineering

Cross-functional collaboration

Communication skills

Education

Science or Engineering degree

Job description

Fisher & Paykel Healthcare in Auckland is seeking a Quality System Engineer (QSE) to join our Design Quality team. You will help release new infant respiratory care and non-invasive ventilation products to global markets by ensuring products meet regulatory and customer requirements.

The role requires strong knowledge of QMS (ISO 13485, 21 CFR 820) and risk management (ISO 14971), plus product verification/validation.