Quality Engineer

Steris Corporation
County Offaly, The Municipal District of Tullamore, Ireland
Contractor
On Site
Mid
0+
Bachelor Degree
Engineering Healthcare Life Sciences

Posted 5 months ago

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Excellent 4.7

Job summary

The Quality Analyst at STERIS is responsible for managing the quality management system in compliance with regulatory standards such as ISO, FDA, and EU GMPs, leading investigations, audits, and continuous improvement initiatives, and supporting production quality activities in a regulated healthcare and life sciences environment.

Responsibilities

The Quality Engineer is responsible for administering the quality management system to ensure adherence to ISO and FDA regulatory standards. This includes leading CAPA investigations, performing internal audits, and overseeing product releases and non-conformance investigations.

Qualifications

CAPA Complaint Handling EU GMPs FDA 21 CFR Part 820/211 ISO 11135 ISO 11137 ISO 13485 ISO 17025 ISO 9001 Quality Management System

A Bachelor's degree and 3-5 years of experience in Manufacturing/Quality Engineering within an ISO certified environment are required. Proficiency in FDA QSR/EUGMP regulations and strong statistical analysis skills are highly preferred.

English

Company

Steris Corporation

Steris Corporation

linkedin
Medical Equipment Manufacturing
Location
County Offaly, The Municipal District of Tullamore, Ireland
Website
steris.com

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Excellent 4.7
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