Job Description

Job Title: Quality Investigations Analyst (Contractor) Location: Global medical device company in Houston, TX The contract duration is initially through the end of 2021, with possible extension Duties: Leads or manages investigations to identify root causes, coordinates determination and implementation of corrective actions and preventive action (CAPA) plans in products and/or processes. Assures timely completion of CAPAs. Provides subject matter expertise within the assigned field of operation to troubleshoot process, material, and technique-related issues. Monitors the site specific indicators for CAPAs/Deviations/Complaints/Yield/CPP/CQA as appropriate and escalates potential outliers or negative trends as needed. Works with the Supplier Management Organization to mine, analyze data and drive root cause analysis and corrective actions that will help eliminate supplier related quality issues. Analyzes data/metrics using sound statistical practices. Develops and implements solutions based on statistical analysis. Supports the preparation of periodic reporting for Complaints processes and helps drive improvements in local and global Complaints Handling. Supports field action assessments and regulatory requests related to complaints and customer communications. Researches and writes special investigations for trends. Reacts quickly to trends and issues detected by quality intelligence data and effectively addresses them. Generates risk assessments related to product/component non-conformances. Skills:

• Communicates clearly
• Works well with others
• Has leadership capability and is self starter
• Ability to learn and retain many complex processes quickly
• Focuses on detail/quality
• Experience writing technical protocols/reports
• Ability to use MS Word/Excel/Powerpoint/Project
• Root cause analysis experience to determine cause of issues
• Knowledge of statistics
• Experience in Medical Device industry - Manufacturing / Design / Quality Engineering fields - preferred Education: Minimum of Master's Degree in Engineering field; Preferably Biomedical Engineering or Bioengineering

Company Description

A WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.