Quality Assurance Specialist

1 week ago

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

We are seeking a Quality Assurance Specialist to assist in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards.


This role coordinates document control transactions, site record retention, calibration and inspection activities, ensuring compliance with regulatory requirements.



Key Responsibilities:

  • Complete document control transactions and manage Customer complaint investigations
  • Facilitate CAPA and NCR investigations and coordinate investigation documentation
  • Review DHR's 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 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


STERIS is an equal opportunities employer and welcomes applications from all qualified candidates.


STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.


We help our customers create a healthier and safer world by providing innovative healthcare, life sciences and dental products and services.


STERIS strives to be an Equal Opportunity Employer.

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