Ottobock - Salt Lake City, UT

posted 3 days ago

Full-time - Entry Level
Hybrid - Salt Lake City, UT
5,001-10,000 employees
Merchant Wholesalers, Durable Goods

About the position

The Quality Technician at Ottobock HealthCare is responsible for ensuring compliance in the processing of Device History Records (DHRs) and the final product release. This role involves inspecting incoming components, maintaining calibration of measurement devices, and supporting the Quality Team in upholding and improving Quality Systems in accordance with FDA and ISO standards. The position is integral to maintaining product quality and regulatory compliance within the healthcare industry.

Responsibilities

  • Review Device History Records and documentation to meet FDA and ISO quality standards.
  • Inspect components and documentation to ensure compliance with regulatory requirements.
  • Conduct incoming inspections of components, verifying critical dimensions against specifications.
  • Use measurement instruments accurately and ensure proper calibration of tools and equipment.
  • Maintain precise and complete records of inspections and quality findings.
  • Identify and track any nonconformities found in products or processes.
  • Coordinate timely equipment calibration and verification with relevant teams.
  • Partner with production teams to promote understanding of quality documentation and practices.
  • Support continuous improvement of the Quality System with the Quality Team.
  • Maintain a clean, safe work environment and provide guidance to others as needed.
  • Perform other duties as assigned.

Requirements

  • High School Diploma (or GED) required.
  • Strong attention to detail.
  • Good communication skills.
  • Ability to read and write English fluently.
  • Experience in Medical Device industry preferred.
  • Experience in QA/QC function preferred.
  • Knowledge of FDA regulations and ISO standards preferred.
  • GDandT fundamentals experience preferred.

Benefits

  • Medical
  • Vision
  • Dental
  • Health savings accounts with employer contribution
  • Flexible spending account options
  • Company-paid life insurance policy
  • Paid time off
  • Company holidays
  • Floating holidays
  • 100% company-paid short and long-term disability
  • 401k match up to 3.5%
  • Paid parental leave
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