Quality Specialist

Steris plc.; Blyth; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading healthcare solutions provider located in Blyth, England, is seeking a Quality Specialist. The role includes assisting with the administration of quality functions to comply with ISO 9001, ISO 13485, and other regulatory standards. Responsibilities include managing customer complaints, facilitating investigations, and tracking quality data. This position offers an opportunity to make a difference in the medical and pharmaceutical industries while ensuring patient safety.

Responsibilities

• Assist in the administration of quality functions to assure adherence to regulatory standards.
• Complete document control transactions.
• Manage customer complaint investigations.
• Facilitate CAPA and NCR investigations.
• Review DHR's and support batch record release.
• Support site inspection activities.
• Support supplier quality assessments.
• Track and trend site quality data.
• Support targeted Lean activities.

Job description

Overview

Do you want to spend your working time making a difference in the world around you? Are you passionate about supporting the medical and pharmaceutical industries? Do you care about keeping patients and people safe? If so, then a career with Steris could be a great fit for you.

Responsibilities

The Quality Specialist is responsible for assisting 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.

• Complete document control transactions.
• Manage Customer complaint investigations and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
• Review DHR's and support batch record release.
• Support site inspection activities and recordkeeping.
• Support supplier Quality and Customer assessment activities.
• Track and trend site Quality data.
• Support targeted Lean activities.
• Complete other duties as assigned.