Senior Quality Systems Engineer

About the Role

Join a committed team focused on improving healthcare solutions as a Senior Quality Systems Engineer at Fisher & Paykel Healthcare. You will play a key role in ensuring new and current medical device products meet stringent market, business, and international regulatory criteria while accelerating product market introductions. This opportunity includes two openings—one supporting the Infant Care team and another within the Invasive Ventilation and Humidification (IV&H) team.

In the Infant Care segment, you will collaborate closely with product development, clinical, marketing, and regulatory teams to launch new products across diverse markets and ensure ongoing compliance of existing products. The IV&H team focuses on maintaining and enhancing mature products while exploring new opportunities, partnering with multiple departments to ensure regulatory adherence and quality improvements.

Key Responsibilities

You will serve as a subject matter expert in Design Controls and lead continuous enhancements to the Quality Management System (QMS). Your duties include delivering training and support to enable the Infant Care or IV&H teams to meet their business objectives and maintain full compliance with QMS and regulatory standards.

Candidate Profile

• At least 5 years of relevant experience in quality engineering within the medical device or comparably regulated industry, specializing in design quality.
• A tertiary qualification in Science or Engineering.
• Familiarity with quality management standards such as 21 CFR 820 and ISO 13485.
• Proven experience in product verification and validation processes.
• Deep understanding of risk management per ISO 14971.
• Knowledge of the FDA and various international regulatory frameworks, including EU regulations.
• Experience managing effective Corrective and Preventive Actions (CAPAs).
• Expertise with change control procedures.
• Use of statistical analysis methodologies.
• Preferably some background in usability engineering.
• A comprehensive approach to product development.

Additional soft skills include excellent communication abilities for influencing and collaborating respectfully, capacity to build strong internal relationships, data-driven and risk-based decision-making skills, as well as a proactive mindset for continuous improvement.

Company Culture & Benefits

Fisher & Paykel Healthcare promotes an inclusive culture that encourages cooperative problem-solving and innovation. Benefits offered include:

• Employee share purchase plan.
• Bi-annual profit sharing and annual performance salary reviews.
• Generous paid parental leave.
• Life, critical illness, and income protection insurance.
• Discounted health insurance and banking/insurance services.
• Engaging employee social clubs and community groups.
• Comprehensive training opportunities and career development paths.
• Support for family-friendly programs, including school holiday subsidies.
• Access to campus amenities such as parking, green spaces, subsidized cafeterias, and advanced facilities.

About Fisher & Paykel Healthcare

A leader in medical device innovation, Fisher & Paykel Healthcare designs and markets products to over 120 countries worldwide, driven by a mission to improve patient outcomes with pioneering healthcare solutions. The company values diversity and community, supporting employee-led groups representing various backgrounds, and fostering an empathetic recruitment process.

Additional Information

Requisition ID: 6818
Application deadline: August 27, 2026