Senior Quality Systems Engineer

About the role

We have two Senior Quality Systems Engineer (QSE) positions available—one within our Infant Care team and the other with the Invasive Ventilation and Humidification (IV&H) team, both based in our head office in Auckland, New Zealand. Immigration and relocation support will be provided to the successful candidate.

In the Infant Care team, you will partner with product development, clinical, marketing, and regulatory teams to release newly developed products to various markets and support compliance of existing products in current and expanding markets. Infant Respiratory Care offers a vast range of new and existing products, making it an exciting area to contribute.

In the IV&H team, you will collaborate with product development, clinical, marketing, regulatory, operations, and other quality teams to support compliance and improvement of mature products and new opportunities. In both roles, you will identify and implement Quality Management System (QMS) improvements, serve as a subject matter expert for Design Controls, and provide training, development, and guidance to support business goals while ensuring compliance with QMS and regulatory requirements.

Responsibilities

• Partner with cross-functional teams (product development, clinical, marketing, regulatory, operations) to release new products and maintain compliance of existing products.
• Identify and implement improvements to the Quality Management System (QMS).
• Serve as a subject matter expert for Design Controls.
• Provide training, development, and guidance to support business plan achievement and regulatory compliance.
• Lead effective Corrective and Preventive Actions (CAPAs).
• Support product verification and validation activities.
• Apply risk management principles (ISO 14971) and statistical analysis techniques.
• Drive continuous improvement with a data-driven, risk-based approach.

Requirements

• Minimum 5+ years of experience in the medical device industry or a similar highly regulated industry, with specific experience in Design Quality Engineering.
• Tertiary qualification in Science or Engineering.
• Understanding of quality management systems such as 21 CFR 820 and ISO 13485.
• Experience with product verification and validation activities.
• Strong understanding of risk management (ISO 14971).
• Knowledge of FDA and international regulations, including EU requirements.
• Experience with change control processes.
• Exposure to statistical analysis techniques.
• Ideally, experience in usability engineering.

Skills

• Excellent communication skills with the ability to influence, negotiate, and challenge respectfully and diplomatically.
• Ability to build relationships at all levels within the organization.
• Strong decision-making skills based on risk and data.
• Curious, inquisitive nature with a continuous improvement mindset.
• Holistic approach to product development.

Benefits

• Employee share purchase scheme.
• Discretionary bi-annual profit share and annual performance-based salary review.
• Generous paid parental leave.
• Life, critical illness, and income protection insurance.
• Discounted health insurance and other banking/insurance discounts.
• Active social clubs and community groups.
• In-house training programs and excellent career progression opportunities.
• School holiday programme subsidy.
• Free parking, beautiful campus with green spaces, and subsidised cafés.
• Access to state-of-the-art facilities.

About Us

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally. Our commitment to care unites us, driving us to improve patient care and outcomes through inspired and world-leading healthcare solutions. We foster an inclusive work environment founded on trust, respect, and cooperation, with employee-led communities such as Spectra (rainbow), Manaaki (Māori), and Women in Engineering playing a key role in our culture. We are dedicated to creating a positive impact on society through our support of organizations like Diversity Works NZ, Pride Pledge, and Global Women.