Quality Assurance Specialist

6 days ago


Bishop's Stortford, Hertfordshire, United Kingdom STERIS Full time

About STERIS

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. Our mission is to help our customers create a healthier and safer world.

Job Summary

We are currently recruiting for a Quality Specialist vacancy. This is an excellent opportunity to join our team in a division that drives the business forwards through innovation.

Key Responsibilities

  • Assist in the administration of quality functions at a site to ensure adherence to regulatory standards.
  • Coordinate document control transactions, site record retention, calibration, and inspection activities.
  • Manage customer complaint investigations and complete complaint documentation.
  • Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
  • Review DHRs and support batch record release.
  • Manage record retention practices within the site.
  • Manage site calibration activities and recordkeeping.
  • Support site inspection activities and recordkeeping.
  • Coordinate internal and external audits.
  • Support supplier quality and customer assessment activities.
  • Track and trend site quality data.
  • Support targeted Lean activities.

Requirements

  • Two (2) years of experience in a regulated industry (FDA/ISO 13485).
  • Customer complaint investigations.
  • Audit coordination.
  • CAPA and NCR investigations.
  • Risk management.
  • Supplier quality and customer assessments.
  • Calibration.

Equal Opportunities

STERIS plc 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 as defined by UK employment law.



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