Alana Renfro

About Alana Renfro

I have over 10 years of experience working in the medical device industry, including experience in quality, operations, and R&D.I am currently working at Lingo, a new Abbott Division for biowearables, as a Senior Manager for QA. My role manages all post market activities, supplier quality, and the training department. This position entails developing and maintaining post market and supplier activities associated with product quality and complaints of both consumer and medical device products. Additionally, it requires building an entire quality management system to separate from the diabetes division where it can run sufficiently as its own business unit. Since the division split, I have been in charge of post market activities, supplier quality activities, the training department, CAPA, and internal audit readiness.

Experience

1. Senior Manager, Post Market and Supplier Quality - Lingo

   Abbott

   May 2021 — Present · Alameda, CA, US

   Build Lingo Quality Management System as it separates from base Abbott Diabetes Care business to become it’s own legal entity- Manage Supplier Quality, CAPA, Training, Audit Readiness, and Post Market Activities for LingoPost Market Activities- Provide Post Market Quality leadership for the Lingo team which includes Complaints Management, Complaints Investigations, Post Market Compliance, Performance and Compliance Metrics Reporting, and Post Market Surveillance- Assess and build resource needs to assure that the accurate level of quality support is provided to the Lingo team, when needed with the competencies needed- Provide direction / coordination of the following- Activities related to post market compliance for consumer and medical products distributed around the world in accordance to policy and procedures - Activities related to global complaints management for Lingo team in conjunction with base diabetes business in areas of complaints registration, evaluation, investigation, vigilance reporting, and periodic summary reports to regulatory agencies around the world- Activities related to quality metrics reporting, including key performance indicators and compliance indicators- Activities related to post market surveillance, including periodic reporting for medical devices and in vitro diagnostic devices and collaborating with stakeholders to identify and gather essential inputs to the process and reports- In the area of post market quality assurance to drive proactive quality improvements while meeting consumer and medical device standards

Education

• University of Southern California

  Master of Science - MS, Biomedical/Medical Engineering

• University of Southern California

  Bachelor of Science - BS, Biomedical/Medical Engineering

Skills

• Process Monitoring
• Matlab
• Medical Devices
• Word
• Labview
• Agile
• Systems Engineering
• Validation
• Research
• Powerpoint
• Microsoft Excel
• Microsoft Word
• Software Documentation
• Time Management
• Sharepoint
• Quality System
• Microsoft Office
• Spanish
• System Testing