Quality Technician Jobs

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Quality Technician

STERISPlymouth, MN
Onsite

About The Position

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. 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.

Requirements

  • Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks AND a high school diploma or equivalent.
  • Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks AND an associate degree.
  • PC experience and familiarity of common desktop applications including Excel and Word.
  • 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.
  • collaborate with others.
  • work in a professional manner to support team actions.
  • effectively manage work tasks.

Nice To Haves

  • Previous experience working as a Quality Technician in a regulated, chemical manufacturing industry.
  • Experience working in systems like Trackwise, SAP, and Propel to manage products and track work instructions.
  • Continuous improvement or process improvement experience in a work setting.
  • Overall passion for process improvement and asking "why" things happen to help resolve issues.
  • Expereince working with Lean Manufacturing principles.
  • ISO/FDA audit experience.

Responsibilities

  • 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.
  • Complete other duties as assigned.

Benefits

  • 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

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