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 at 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 the 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 the compliance and improvement of mature products and new opportunities. In both roles, you will identify and implement Quality Management System (QMS) improvements and serve as a subject matter expert for Design Controls. You will also provide training, development, and guidance to support the achievement of business plans while ensuring compliance with QMS and regulatory requirements.

Requirements

• A minimum of 5+ years of related experience in the medical device industry or a similar highly regulated industry, with specific experience in Design Quality Engineering.
• A tertiary qualification in Science or Engineering.
• An understanding of quality management systems such as 21 CFR 820 and ISO 13485.
• Experience with product verification and validation activities.
• A strong understanding of Risk Management (ISO 14971).
• An understanding of FDA and international regulations, including the EU.
• Experience leading effective CAPAs and change control processes.
• Exposure to statistical analysis techniques.
• Ideally, experience in usability engineering.
• A holistic approach to product development.

Skills

• Excellent communication skills with the ability to influence, negotiate, and challenge with respect and diplomacy.
• Ability to build relationships at all levels within the organization.
• Ability to make risk-based, data-driven decisions.
• A curious and inquisitive nature with a continuous improvement mindset.

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 and insurance discounts.
• Active social clubs and community groups.
• In-house training programs from external providers and excellent career progression opportunities.
• School holiday programme subsidy.
• Free parking, a 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, cooperation, and respect, with employee-led communities such as Spectra (rainbow), Manaaki (Māori), and Women in Engineering playing a key role in our culture. We are also committed to creating a positive impact on society through our support of organizations like Diversity Works NZ, Pride Pledge, and Global Women.