Quality Technician

Quality Technician

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 investigations. In 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 You'll 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 DHR's 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.

Skills, Abilities, & 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).
• Experience 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.