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Company: MillenniumSoft Inc.
Contact Name: Edwin George

Job Details: Quality Engineer Date: Sep 30 2022

Job Reference: 154001
Job Category: Engineering Jobs [ View All Engineering Jobs Jobs ]
Company Type Employer
Employment type: Full Time
Degree: Bachelors
Experience: 2 years
Location: Tempe, Arizona, 85281
Job Skills: TMVs, Component Qualifications and Analytical Testings
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Job Description

Position : Quality Engineer
Location : Tempe, AZ
Duration : 9 Months
Total Hours/week : 40.00
1st Shift
Client: Medical Device Company
Level Of Experience: Entry Level
Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Work hours: First shift – 8am-5pm but can have some flexibility.

3 Must haves on the resume: Experience with TMVs, Component Qualifications and Analytical Testings

• Education requirements? Bachelor’s Degree

Job Description:
• Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers, and other cGMP activities for the assigned product lines in the instrument plant.
• Oversee operations and assure documentation and procedures are followed, updated, and maintained 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 2 years of experience, or MS with no experience required (project management experience preferred).
• Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or another 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.
• Working knowledge of statistical methods as well as statistical application software.
• 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.
• Professional certification is an advantage (i.e., CQA, CQE, SQE, CQM, Six Sigma, etc.).

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