Quality Systems Engineer - Design

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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. You will work in partnership with our design and development engineering teams to collaborate on product development, release newly developed products to various markets, and support conformance/compliance of 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
• Acting as the subject matter expert for questions and support on the QMS

Requirements

• Minimum of 3 years related work experience in either Quality Engineering, or a similar technical field
• Electronics background or experience supporting complex electronic devices highly advantageous
• Experience in a highly regulated manufacturing and design environment, with medical devices experience highly advantageous
• Working knowledge of the regulations that apply to the medical devices industry; understanding of electronic‑focused regulations preferred
• Understanding of the Quality function and its impact on the business

Qualifications

• A tertiary qualification in Science or Engineering (ideally industrial, bio‑medical or mechanical)

Skills

• Ability to build strong relationships, work collaboratively, share knowledge, and act as a guiding hand to the OSA product group regarding quality discussions
• Excellent communication skills with the ability to share complex ideas, positively influence, negotiate, and challenge with respect and diplomacy
• Strong problem‑solving ability (both through independent thinking and collaboration across the business) and strong resilience when navigating problems

Benefits

• Employee share purchase scheme
• Discretionary bi‑annual profit share
• Generous Paid Parental Leave
• Life, Critical illness and Income Protection Insurance
• Discounted Health Insurance
• Active Social clubs & community groups
• In‑house training programs from external providers
• Purchasing privileges for Fisher & Paykel Healthcare products
• School holiday programme subsidy
• Banking and Insurance discounts
• Free Parking
• Beautiful campus with green spaces including EV charging stations and end‑of‑trip facilities to encourage lower‑impact transport choices
• Subsidised Café’s
• Annual Salary Review
• High rates of internal promotion