Quality Specialist

Steris Corporation•Pagedale, MO

32d•Onsite

About The Position

The Quality Specialist in our St. Louis, Missouri manufacturing facility 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. In this role, you will coordinate document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process. This position requires working onsite in our St. Louis, Missouri manufacturing facility Monday through Friday from 8am to 5pm.

Requirements

Associates degree Engineering or Scientific field, and a minimum of 2 years of experience in a Quality function within a regulated industry (i.e. FDA/ISO 13485).
In lieu of a degree, a high school diploma/ GED and a minimum of 6 years of experience in a regulated industry (i.e. FDA/ISO 13485).
Working familiarity of common desktop applications including Microsoft Office applications such as Excel and Word.

Nice To Haves

Experience working large data sets and analyzing trends.
Proficiency using Excel to export data and manipulate data sets using pivot tables or other methods.
Understanding of national sampling standards (ANSI -Z1.4).
Demonstrates a “Customer first” mindset. Responds with a sense of urgency.
Collaborates with others. Works in a professional manner to support team actions.
Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities.
Constructs clear written communication. Keeps manager and co-workers informed.

Responsibilities

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 (Device History Record) 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.
Complete other duties as assigned.