Quality Systems Engineer - Design
Fisher & Paykel Healthcare · Minneapolis, MN · 2 wk ago
On-siteDesignFull-time
About the role
We have an exciting opportunity for a Quality Systems Engineer to join the Design Quality Team supporting our OSA product group based in our head office in Auckland, New Zealand. Immigration and relocation support would be provided to our preferred candidate. Working in partnership with our design and development engineering teams, you will collaborate with Product development to release newly developed products to various markets. You will also support the conformance/ compliance of existing products in their markets. Using your technical and Quality expertise you will ensure design assurance of new and existing products.
Responsibilities
- Leading the activities related to the use of design controls
- Managing the implementation of our Quality Management System (QMS) to maintain compliance
- Ensuring product quality for an effective and efficient product commercialization
- Identifying and implementing QMS improvements
- Being the subject matter expert for questions and support on the QMS
Requirements
- A minimum of 3 years related work experience in either Quality Engineering, or in a similar technical field
- An electronics background or experience supporting complex electronic devices would be highly advantageous
- Experience in a highly regulated manufacturing and design environment, with medical devices experience highly advantageous
- A working knowledge of the regulations that apply to the medical devices industry