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Quality Assurance Specialist

2 months ago

Bishop's Stortford, Hertfordshire, United Kingdom STERIS Full time
{"title": "Quality Specialist Role", "description": "

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

About the Role

We are seeking a Quality Specialist to join our Medisafe team, responsible for ensuring adherence to regulatory standards and quality functions at our site.

Key Responsibilities

  • Coordinate document control transactions and site record retention.
  • Manage customer complaint investigations and complete complaint documentation.
  • Facilitate CAPA and NCR investigations and coordinate investigation documentation.
  • Review DHRs and support batch record release.
  • 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 years of experience in a regulated industry (FDA/ISO).
  • Customer complaint investigations.
  • Audit coordination.
  • CAPA and NCR investigations.
  • Risk management.
  • Supplier quality and customer assessments.
  • Calibration.

Equal Opportunities

STERIS is an equal opportunities employer, committed to diversity and inclusion.

", "lang_code": "en-US"}