Quality Engineer - Root Cause Analysi...
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Sep
18
Sandeep Singh Dhillon
Quality Engineer – Root Cause Analysis/Medical Device/Investigation from Randstad Engineering
Pharma Job Portal
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This Job is located in Marion, NC -> United States

About the Job

Global medical device manufacturer has an immediate need in Marion NC for a Quality Associate III- Investigation Owner. This is a perm position and offers relocation assistance for the right candidate. The deviation owner leads the investigation of deviations that occur in operations and is responsible for authoring the investigation summary report. Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause and corrective and preventive actions. Interacts will all levels of staff and provides status updates as well as present the strategy for closure of deviations. Manage several investigations at a time.

Responsibilities for the Quality Engineer

Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures. Determine appropriate preventive actions to avoid reoccurrence of the deviation
Conduct personnel interviews to determine root cause of the deviation
Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate
Set up and run meetings with cross functional teams
Close deviations in a timely manner to meet business and compliance needs
Work with Subject Matter Experts and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective and preventive actions, complete trending analysis, and recommend product disposition
Present and defend investigations during regulatory inspections, as required
Requirements for the Quality Engineer

Bachelor’s degree in science or engineering
2-3 years of experience in root cause evaluation, interpreting regulations and quality systems within the medical device or pharmaceutical indsutry
5-8 years of experience in Manufacturing Operations and or Quality, or related field in the medical products industry
Must have a thorough understanding of pharmaceutical manufacturing process and equipment, preferably parenteral solutions, and current Good Manufacturing Practices (cGMPs)
Must have good analysis, troubleshooting, and investigation skills
Must be able to put complex thoughts and issues into writing in such a manner than an educated, but uninformed reader can understand and make decisions based on the written investigation report

Apply at http://engineers.randstadusa.com/think.nsf/b2_apply1?openform&jt=Quality%20Engineer&ParentUNID=CC1F769477EDCE7A85258167006D17F2&frm=mon_kw&mdm=job%2Bpost&nme=Job%2BBoards&frm1=mon_kw



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