Erika A. Stephens Email & Phone Number

Tustin, Ca, Us

Irvine, California, United States

Irvine, California, United States

Irvine, California, United States

● Authored a Final Clinical Study Report, an End-of-Life IDE Supplement, and various Quality System change notifications to multiple Notified Bodies (GMED/NSAI).● Acted as the Lead Auditor for 12 Internal Audits and supported 29 Internal Audits as an auditor on the audit team across multiple business sites.● Remediated historical recall files and wrote re-requests for closure that were submitted to FDA for two older files (2018 and 2020).● Authored nine (9) Health Hazard Evaluations which each included a hazard analysis, health risks, compliance assessment, and risk evaluation.● Completed regulatory assessments for quality system changes through the document change order process.● Served as the key SME for the Internal Audit program and Device Tracking during the MDSAP certification audit. In addition, provided front and backroom external audit support.● Led audit activities for 483 Inspection Follow-up activities. This included developing/maintaining 483 support binders and having regular training sessions with SMEs.

Fullerton, California, United States

Fullerton, California, United States

Huntington Beach, California, United States

● Supervising and training employees, delegating responsibilities, and developing positive relationships with staff● Run store operations including opening and closing the store● Ensuring proper cash management and cash register policies

Huntington Beach, California, United States

Riverside, California, United States

● Collected petitions and pledges through organizing grassroots efforts ● Talked to Congressmen and Assemblymen in Sacramento about the Bag Ban and received endorsements● Recorded and distributed notes of each meeting using Google Drive● Led general meetings when the Chair was absent