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Quality Assurance Specialist

1 month 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.

Key Responsibilities

  • Complete document control transactions to ensure compliance with regulatory requirements.
  • Manage customer complaint investigations and document findings.
  • Facilitate CAPA and NCR investigations, coordinating documentation as needed.
  • Review DHRs and support batch record release to ensure quality and safety.
  • Manage record retention practices within the site to maintain compliance.
  • Coordinate site calibration activities and recordkeeping to ensure accuracy.
  • Support site inspection activities and recordkeeping to maintain compliance.
  • Coordinate internal and external audits to ensure regulatory compliance.
  • Support supplier quality and customer assessment activities to ensure quality and safety.
  • Track and trend site quality data to identify areas for improvement.

Required Experience

  • Two years of experience in a regulated industry, such as FDA/ISO 13485.
  • Customer complaint investigations and audit coordination.
  • CAPA and NCR investigations, risk management, and supplier quality and customer assessments.

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.