Role Summary
We are seeking a seasoned professional to lead our Supplier Quality Engineering efforts. As Senior Quality Engineer, you will provide technical leadership and support the monitoring, approval, and appraisal of suppliers from a quality perspective.
Key Responsibilities
* Drive all assigned projects in a structured fashion, ensuring timely completion in compliance with relevant procedures.
* Manage project activities to achieve milestones.
* Represent the team at review meetings.
* Build effective relationships with Operations, IT, Engineering, and Regulatory teams.
* Lead FDA, QSR, and ISO13485 requirements, promoting best industry practices and making decisions using the Quality Engineering Manager as the final arbitrator on critical quality issues.
Requirements
* Third Level qualification in Science, Engineering, or a relevant technical discipline.
* Familiarity with relevant ISO, EU, and FDA medical device standards regulations is required.
* Qualified Lead Auditor, preferably within the Medical Device Industry, is desirable.