Chemical Manufacturing Quality Technician Job at STERIS - Manufacturing Facilities, Minneapolis, MN

  • STERIS - Manufacturing Facilities
  • Minneapolis, MN

Job Description

Job Description

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.

HOURS: 1st shift (5-6am start) + overtime as needed

LOCATION: 41905 28th Ave North Plymouth, MN

PAY: $23 - $29hr (biweekly pay) + bonus

HIRE TYPE: Direct, full time.

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, and Experience:

Required:

  • Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks with a high school diploma or equivalent.- Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks with an associate degree.

  • Ability to- work in a fast-paced environment with strict deadlines.

    • generate detailed, high-quality documentation.
    • work with others in analyzing and solving technical problems.
  • PC experience and working familiarity of common desktop applications including Excel and Word.

  • Experience with mathematical skills including ratios, proportions and basic algebra.

Preferred:

  • Experience working in a chemical manufacturing/production environment.
  • Continuous Improvement/Process Improvement experience.
  • Attention to detail.
  • Hazardous materials experience.
  • Experience working with FDA (CFRA20/GMP&GDP) and/or ISO or similarly regulations.
  • Experience utilizing Trackwise, SAP, Propel systems.

Other:

  • Lifting, Pushing, Pulling 25-50lbs
  • Bending,Walking,Standing,Sitting,Typing,Hand Manipulation
  • Visual Acuity(mostly in reference to investigations/picking through cases/moving some cases/boxes as needed)
  • This is a safety sensitive position

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 (PTO) and (9) added Holidays.

  • Excellent Healthcare, Dental, and Vision Benefits.

  • Long/Short term disability coverage.

  • 401(k) with a company match.

  • Maternity & Parental Leave.

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

  • Tuition Reimbursement and continued education programs.

  • Opportunity for advancement in a stable long-term career.

You should be proficient in:

  • Continuous Improvement
  • 5 Why (Root Cause Analysis Method)
  • FDA Regulations
  • Good Manufacturing Practices (GMP)
  • Microsoft Excel
  • 5S
  • CFRA20
  • chemical manufacturing
  • GDP
  • ISO Regulation
  • microsoft office
  • basic algebra

Machines & technologies you'll use:

  • Propel
  • Trackwise
  • SAP

Job Tags

Full time, Temporary work, Work at office, Local area, Day shift

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