QA Technician II

Company: Techlink Systems Inc.
Location: Minnetonka
Posted on: May 15, 2022

Job Description:

Job DescriptionJob Title: QA Technician IILocation: Minnetonka, MN (On-site)Contract Duration: Contract until 12/31/2022Work Hours: Monday to Friday, 10AM - 6PM. Can start as early as 10 AM or as late as 12 NN. Option to work 4x10 (e.g. M to Th or Tues to Fri, 10-hour days) instead of Monday to Friday.RESPONSIBILITIES:

• Conducting paperwork reviews in accordance with GDP (Good Documentation Practices)
• Reviewing the DHR (Device History Record) paperwork created by the production line, ensuring compliance/addressing noncompliances
• Providing technical support when issues occur on the production line
• Partnering with internal teams to resolve quality issues.They will spend half of their time at a desk and the other half on the manufacturing floor.Work Schedule:
  • This will be a split shift type of schedule. Ideally, they should start working between 10 AM to 12 NN and then work 8 or 10 hours daily.
  • They have the option to do either a 5x8 (regular Monday to Friday) or 4x10 (Monday to Thursday/Tuesday to Friday) shift.
  • The 1st shift is from 4:30 AM to 3:00 PM while the 2nd Shift is from 3:00 PM to 2:00 AM. The goal is for this person to provide support to both shifts.EDUCATION REQUIREMENTS HS Diploma or GED minimumREQUIRED EXPERIENCE
    • 2+ years of Quality experience desired.
    • Med device, pharma, or other FDA-regulated industry experience required.
    • Knowledge of GDP standards.
    • Previous experience with DHR reviews.
    • Critical thinking and communication skills.

Keywords: Techlink Systems Inc., Minnetonka , QA Technician II, Professions , Minnetonka, Minnesota