Quality Assurance Specialist

4 weeks ago


Edmonton, Alberta, Canada STERIS Full time

At STERIS, we strive to create a healthier and safer world by providing innovative healthcare and life science solutions. As a Quality Assurance Specialist, you will play a crucial role in ensuring our products and services meet the highest standards of quality and regulatory compliance.

Key Responsibilities:

  • Assist in the administration of the quality management system to ensure adherence to ISO 9001, ISO 13485, and other applicable regulatory standards.
  • Lead complaint/CAPA investigations, supplier quality improvement initiatives, and continuous improvement activities.
  • Coordinate and perform problem-solving investigations, pre-reviews, and final acceptance/run release of processing runs that contain non-conformances.
  • Support production and quality operations by ensuring all product processing requirements are met in accordance with customer specifications.

Requirements:

  • Bachelor's Degree.
  • 1-5 years of combined manufacturing/quality engineering and/or quality systems experience.
  • 1-5 years of experience working in an ISO certified environment.

Preferred Experience:

  • Working knowledge of FDA QSR/EUGMP regulations.
  • 1-5 years of experience with medical device or other regulated industries.

Skills:

  • Excellent problem-solving skills.
  • Focus on identification of potential issues and continuous improvement.
  • Experience working on cross-functional teams and on own initiative.
  • Demonstrated excellent organizational, oral, and written communications skills.

Work Schedule:

  • This is an onsite schedule position.
  • 5% - 10% international and domestic travel.


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