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STERIS - Manufacturing Facilities
Manufacturing Quality Technician - AsepticSTERIS - Manufacturing Facilities • St. Louis, MO, US
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Manufacturing Quality Technician - Aseptic

Manufacturing Quality Technician - Aseptic

STERIS - Manufacturing Facilities • St. Louis, MO, US
8 days ago
Salary
$20.43–$25.00 hourly
Job type
  • Full-time
Job description

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 investigations. In addition, Quality Technicians may review device history records, authorize release of finished product/processes and execute calibration and environmental monitoring processes.

SHIFT: 2pm - 10:30pm (2nd shift) + overtime as needed

PAY: $20.43 - $25hr + 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).
  • 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.

What STERIS Offers:

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.

Here is just a brief overview of what we offer:

  • Market Competitive Pay

  • Extensive Paid Time Off and (9) added holidays

  • Excellent Healthcare, Dental and Vision Benefits

  • Long/Short Term disability coverage

  • 401(k) with company match

  • Maternity & Paternal Leave

  • Additional add-on benefits/discounts for programs such as Pet Insurance

  • Tuition Reimbursement and continued educations programs

  • Excellent opportunities for advancement and stable long-term career

You should be proficient in:

  • Hazardous Materials
  • Lean Manufacturing Principles
  • Good Manufacturing Practices (GMP)
  • Experience in a Manufacturing Environment
  • Aseptic
  • Aseptic Gowning
  • ISO 9001
  • Oracle System Experience
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Manufacturing Quality Technician - Aseptic • St. Louis, MO, US

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