Job description:
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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 and sustaining customer, business and international regulatory requirements.
We have 2 positions available - ones within our Infant Care team and the other one 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 the successful 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.
About You
We are looking for someone with:
A minimum 5+ years related experience in the medical device industry, or a similar highly regulated industry, with s