Quality Technician 3rd Shift

Position Summary:

The Quality Technician is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001 ISO 13485 MDSAP FDA 21 CFR Part 820/211 EU MDR and other applicable regulatory standards. The Quality Technician supports manufacturing and servicing operations by assisting in performing and documenting problem-solving investigations and conducting in-process sub-assembly and final QC product acceptance testing.

Quality Technicians assist in identifying and documenting process and product non-conformances. They work with operations team members to perform and document problem-solving addition Quality Technicians may review device history records authorize release of finished product/processes and execute calibration and environmental monitoring processes.

SHIFT: 10:30pm - 6:30am (3rd shift) overtime as needed

PAY: $20.43 - $26.44hr quarterly bonus

LOCATION: 7405 Page Ave St. Louis MO

What youll do:

• Assists in production line Quality investigations and associated problem-solving activities.
• May coordinate and conduct in-process and final QC product acceptance testing depending on facility.
• Investigates production line stoppages to identify corrective actions.
• Identifies and documents product and process non-conformances.
• Participates on a Material Review Board to review and process non conformance reports.
• Reviews DHRs and supports batch record release.
• Enters and retrieves Quality data from local and global systems.
• Performs site calibration activities and recordkeeping.
• Executes environmental monitoring processes and recordkeeping.
• Verifies calculations dose ranges dosimeter placements and special instructions prior to processing and part of final product release.

Required Experience

Required:

• High School Diploma with 3 years of experience in a manufacturing/repair environment/other technical production OR Associates Degree with 1 year of experience in a manufacturing or repair environment.
• Experience with math including ratios proportions and basic algebra.
• Ability to:
  • Work in a fast-paced environment with strict deadlines.
  • Read and comprehend written instructions safety warning labels and machine instruction manuals.
  • Generate detailed high-quality documentation.
  • Work with others in analyzing and solving technical problems.
  • Collaborate with others and works in a professional manner to support team actions.
  • Work with minimal supervision and have basic computer skills including Excel and Word.
  • Cross train in aseptic department.
• May be expected to move carry and lift approximately 50 pounds.

Preferred:

• Previous experience in a regulated industry: ISO 13485 & FDA specifically.
• Previous experience in aseptic gowning.
• Previous experience with GDP (good documenting processes).
• Expereince working in chemical manufacturing.

Other:

• Position requires bending walking standing sitting typing hand manipulation and visual acuity.
• Ability to lift push and pull between 25lbs to 50lbs as needed.