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Quality Assurance Technician II
Location:  Saint Paul, MN 
Recruiter Name:  Sam Rima
Phone:  (651) 600-3702
Job ID:  15589
Category:  Quality Assurance
Job Type:  Direct Only
Minimum Experience:  5+
Required Education:  Associate of Applied Science
Salary:  $ 24.00 - $ 35.00
Job Description
Konik PrimeStaff is partnering with a growing medical device company on the east side of town that is seeking to add an experienced Quality Assurance Technician to their team for a 2nd shift opening (2:30pm to 11:00pm M-F) on a direct hire basis. This individual will perform in-process quality monitoring, inspecting, and testing activities as well as medical device/drug batch record review/release. The ideal candidate will be comfortable working independently without direct supervision and will have high attention to detail. If you are looking for a 2nd shift role and are looking for a growing company to utilize your quality background, this might be what you have been looking for!

Quality Assurance Technician II Responsibilities:
  • Support manufacturing with first article inspections and in-process inspection, measurement and test activities including UV/VIS, Instron Strength Test, Visual Inspection, etc.)
  • Perform verification, documentation, investigation, and corrective action related to Material Review Board (MRB) requirements
  • Maintain accurate MRB logs and records, implementing MRB disposition decisions in a timely manner
  • Audit batch records for Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) compliance; release batch and issue certificate of conformity
  • Perform quality control tests, measurements, and inspections and collect data related to incoming materials, bioburden, analytical results, and process controls
Job Requirements

Quality Assurance Technician II Qualifications:
  • Technical degree in Applied Science and/or equivalent ASQ certification and relevant work experience
  • Minimum of 5 years of quality assurance experience in a GMP medical device, pharmaceutical, or food science environment
  • Batch record review and release experience
  • Experience in a cleanroom environment
  • General knowledge of various ISO and quality system regulations (ISO 13485, 11135, 11137, 14644; FDA CFR 829, 210, 211)
  • Basic test lab experience including familiarity with UV/Vis, FTIR, and various physical test methods (gravimetric, tensile, visual)
  • Excellent attention to detail; specifically, strong history of good documentation practices and record keeping
  • Computer skills (Excel, word, Minitab, etc.)
 
Konik PrimeStaff is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.
 
Konik PrimeStaff has been a leader in the technical staffing industry for more than 40 years, providing the fastest and easiest link between employees and employers. Konik PrimeStaff has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service.
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