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Quality Engineer

3 months ago

Santa Clara, United States ICONMA Full time

Quality Engineer Location: Santa Clara, CA

Summary:

This role will provide compliance support to the Regulatory Affairs organization by - Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics. Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks. Supporting quality system integration for acquisitions and new product introductions. Identifying and implementing system and/or systemic processes. Supporting tracking and maintenance of regulatory post-approval commitments. Driving quality system process improvement initiatives

Qualification:

BS Degree and related experience. Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.

Skills Required:

Independent Troubleshooting Critical thinker Ability to drive a problem through resolution and implement mitigations. Ability to handle multiple streams simultaneously.

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. #J-18808-Ljbffr