Quality Engineer/Senior Quality Engineer - Design (Infant Care & NIV) at Fisher Paykel Healthcare Limited

Howick, Auckland, New Zealand -

Full Time

Start Date

Immediate

Expiry Date

02 Sep, 26

Salary

0.0

Posted On

04 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Quality Engineering, Quality Management Systems, Product Verification, Product Validation, Risk Management, Statistical Analysis, Usability Engineering, Design Controls, Regulatory Compliance, Communication Skills, Negotiation, Relationship Building

Industry

Medical Equipment Manufacturing

Description

Care to find solutions Join a team of good people doing good work with intent. People like you, who care to make a difference. About the opportunity Our strong focus on research and development creates a regular flow of new Fisher & Paykel Healthcare products. To enable our ongoing success, we depend on the technical expertise of our Design Quality team, who ensure our products get to market as fast as possible while meeting customer, business and international regulatory requirements. We have the opportunity to join one of our Design Quality teams at a Quality System Engineer (QSE) or Senior QSE level depening on expeirence and current level. Infant Respiratory Care & Non-invasive ventilation has a vast range of new and existing products - it’s an exciting area to be a part of! In your role you will partner with product development, clinical, marketing and regulatory teams to release newly developed products to various markets. You will also support the compliance of existing products in current and expanding markets. As QSE you will also be responsible for identifying and implementing Quality Management System (QMS) improvements, as well as being a subject matter expert for Design Controls. You will provide training, development and guidance to support the achievement of Infant Care’s business plan and ensure compliance to the QMS and regulatory requirements. Depending on the experience of the candidate, we are also open to considering candidates at a Quality Systems Engineer (QSE) level seeking a lateral move into another product group or quality department. About you We are looking for someone with: A minimum 3 years 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 21CFR820 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. Exposure to statistical analysis techniques. Ideally some experience in usability engineering. A holistic approach to product development. You will also have: Excellent communication skills with the ability to influence, negotiate and challenge with respect and diplomacy. An ability to build relationships at all levels within the organization. A curious and inquisitive nature and a continuous improvement mindset. Requisition ID: 6535 Posting end date: 19/06/2026

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Responsibilities

Partner with product development, clinical, and regulatory teams to release new products and maintain compliance for existing ones. Responsible for implementing QMS improvements and serving as a subject matter expert for Design Controls.