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Quality Engineer
3 months ago
Position: Quality Engineer (Must Have Exp Quality Notifications, Complaints )
Location: Tempe, AZ
Duration: 5+ Months Contract
Total Hours/week: 40.00
1st Shift
Client: Medical Device Company
Job Category: Engineering
Level Of Experience: Mid-Seniority Level
Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
No H1B’s
Description:
Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant.
Ensure documentation and procedures are followed as required by internal Quality Policies and related FDA/GMP guidelines.
Conducts complaint investigations, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
BS or BA in related field required with up to 2 years of experience, or MS with no experience required.
Typical degree in Mechanical or Electrical or Industrial or Biomedical Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.
Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA).
Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
Capable of using Microsoft programs and ability to learn other systems.
Utilizing TRACKWISE software is an advantage.
Effective verbal and written communication skills.
The ability to work in teams and independently with minimal supervision to obtain results as required.
Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.
