Quality Engineer - Hercules, CA
Our Client is seeking a quality engineer to support the complaint investigation activities for multiple divisions. They are a manufacturer of products for the life science research and clinical diagnostics markets.
Quality Engineer I
Responsible for maintaining the quality processes to ensure that all product complaints are processed in accordance with established company procedures and standards, including but not limited to assessing risk, investigating root cause, implementing effective long-term corrective actions to prevent recurrence, and potentially reportable events.
• Responsible for ensuring all required information for a complaint file is obtained and properly documented.
• Evaluates all information to ensure appropriate analysis, investigation, and root cause is documented prior to complaint closure.
• Ensure adequate information is received to warrant timely reporting, investigation, and closure of product complaints.
• Responsible for analyzing product quality information (case escalations, trend information, etc.). Provide technical and analytical support to subsidiaries and internal functional areas.
• Product Complaint Handling, Post Market Surveillance, knowledge of the regulation (Medical Device Reporting), GMP (QSR/ISO13485) and Risk Management (ISO14971) regulations and systems.
Requires the following:
• Bachelor’s Degree or equivalent in a technical discipline
• 0-2 years experience or equivalent combination of education and experience
• Basic knowledge of and application of principles and theories of quality engineering
• Understanding of GMP)/ISO regulations and validation regulations is preferred
• Detail oriented with excellent organizational and project management skills.
• Excellent verbal and written communication, problem solving, analytical skills required.
• Critical thinking skills, ability to multitask in a high-pace environment with fast deadlines, and ability to work well under pressure.
• Contribute individually but work as a team.
• Effective communication with various departments.
• Basic computer skills required, including MS Windows, MS Word, MS Excel, MS PowerPoint, Minitab.
• Knowledge/experience with Salesforce complaint management system is a plus.
United States of America
Engineering / Engineering
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Job Title: Quality Engineer
Location: Hercules, CA
Job Type: Temp Position
Reference ID: 362617
Posted Date: 4/4/2019