Job Title : Senior Design Quality Engineer
Summary : Are you looking to get into AI medical devices? My client is working on new AI-driven digital platform that covers multiple chronic conditions/comorbidities, including Type 1 and Type 2 Diabetes, Hypertension, Heart Failure and Prediabetes. With one already FDA-approved platform, my client is looking to continue their success as the digital health space continues to grow. If you are someone who is is a great team player, able to work cross-functionally with other teams and want to be a part of a team that celebrates all kinds of success, this may be the position for you!
The Senior Design Quality Engineer will be responsible for :
-Participate and contribute to the implementation of document and change control processes and systems for compliance to medical device regulatory and QMS requirements.
-Support the management of all QMS and Regulatory Affairs related documentation and records.
-Work directly with authors, reviewers and approvers of document and change control to facilitate workflow, ensure GDP.
-.Conduct periodic reviews and inspections of QMS documentation.
-Maintain complaint records and support regulatory reporting of device incidents.
The Senior Design Quality Engineer should have the following requirements :
ยท Bachelor's Degree in an engineering discipline.
ยท At least 5 years of experience with FDA and ISO regulation product development and quality systems (design controls, production and process controls, CAPA, etc.)
ยท Experienced with MDSAP, ISO13485, ISO 14971, FDA QSR and other regulations.
ยท Experience with Agile methodology.
ยท Experience with any of (or any related) software: JIRA, Confluence, Asana, Basecamp, Smartsheet, Zoho.
If this sounds like something you would be interested in, please apply!