- Location
- Tempe, AZ
- Type
- Contract
- Department
- Engineering
- Experience
- 2+ years
- Source
- ApplicantStack
Description
Position : Quality Engineer
Location : Tempe, AZ
Duration : 5 Months
Total Hours/week : 40.00
1st Shift
Client: Medical Device Company
Job Category: Engineering
Level Of Experience: Mid-Level
Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
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.
- 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.
Skills
GMPFDA