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Quality Assurance Specialist

2 months ago


Hoddesdon, Hertfordshire, United Kingdom STERIS Full time

At STERIS, we strive to create a healthier and safer world by providing innovative healthcare and life science solutions.

Make a Difference

Do you want to contribute to the medical industry and support patient safety? Are you passionate about quality and compliance? If so, a career with STERIS could be a great fit.

We are dedicated to enabling patient safety and driving improvements in quality outcomes and efficiency across all our products and services.

Key Responsibilities

  • Complete document control transactions and manage customer complaint investigations.
  • Facilitate CAPA and NCR investigations and coordinate investigation documentation.
  • Review DHRs and support batch record release.
  • Manage record retention practices and site calibration activities.
  • Support site inspection activities and coordinate internal and external audits.
  • Track and trend site quality data.
  • Support targeted Lean activities and complete other duties as assigned.

Required Experience

  • Two years of experience in a regulated industry (FDA/ISO).
  • Customer complaint investigations and audit coordination.
  • CAPA and NCR investigations and risk management.
  • Supplier quality and customer assessments.
  • Calibration and quality data analysis.

Equal Opportunities

STERIS provides employment and advancement opportunities without regard to age, disability, gender reassignment, marriage or civil partnership, pregnancy and maternity, race, religion/belief, sex (gender), sexual orientation, or any other legally protected characteristic.