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Quality Engineer

Location: Hercules, CA, United States
Job # 12159320
Date Posted: 04-04-2019
Quality Engineer Hercules, CA 94547
Pay Rate: $42.00 per hour
6-8-month long contract


As the Quality Engineer, you will support the complaint investigation activities for multiple divisions.  You will be assisting with implementing the Quality Plan for the LSG Complaint Remediation/Merging of CSD and LSG complaint system to ensure the system is sustainable.

Responsibilities:
  • Maintain 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.
  • Ensure all required information for a complaint file is obtained and properly documented.
  • Evaluate 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.
  • Analyze product quality information (case escalations, trend information, etc.) and 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.
Qualifications:
  • BA 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
  • Proficient in MS Windows, MS Word, MS Excel, MS PowerPoint, Minitab.
  • Knowledge/experience with Salesforce complaint management system is a plus.
Please submit your resume for consideration!

 
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