Senior Quality Systems Engineer

About the role

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 and sustaining customer, business and international regulatory requirements. We have 2 positions available - one within our Infant Care team and the other with the Invasive Ventilation and Humidification (IV&H) team based in our head office in Auckland, New Zealand. Immigration and relocation support would be provided to our preferred candidate. Infant Respiratory Care has a vast range of new and existing Infant Care 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. IV&H has an abundance of mature products and exciting new opportunities. In your role you will partner with product development, clinical, marketing, regulatory, operations and other quality teams to support the compliance and improvement of products currently in the market. As Senior QSE in both of these teams, 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 (or IV&H’s) business plan and ensure compliance to the QMS and regulatory requirements.

Responsibilities

• Partner with product development, clinical, marketing, and regulatory teams to release newly developed products to various markets.
• Support compliance of existing products in current and expanding markets.
• Partner with product development, clinical, marketing, regulatory, operations, and other quality teams to support compliance and improvement of products currently in the market.
• Identify and implement Quality Management System (QMS) improvements.
• Act as a subject matter expert for Design Controls.
• Provide training, development, and guidance to support business plan achievement and ensure compliance to QMS and regulatory requirements.

Requirements

• Minimum 5+ years of related experience in the medical device industry or a similar highly regulated industry, with specific experience in Design Quality Engineering