QC Scientist

Steris Corporation•Pagedale, MO

5d•Onsite

About The Position

The QC Scientist 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. This position is responsible for generating quality control initiatives with minimal supervision including developing test methods and troubleshooting lab and product issues in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to developing test methodologies and validation methods, and audits. The QC Scientist leads non conformances, complaint and CAPA investigations, supplier quality improvement efforts, manufacturing and process control improvements, and product and service quality enhancements through the application of statistical methods and established quality principles. This position requires working onsite in our St. Louis, Missouri manufacturing facility during core business hours.

Requirements

Bachelor’s degree in Science or related technical field with hands on Chemistry experience.
Minimum 6 years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required.
Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics.

Nice To Haves

Bachelor of Science degree in Chemistry, Biology, Chemical Engineering or Physics.
Ability to lead cross functional team meetings sometimes involving Directors and above.
Ability to manage multiple priorities in a fast-paced production environment.
Ability to pivot and reprioritize quickly to meet Customer Needs.

Responsibilities

Lead projects focused on chemical raw material and product quality.
Assist with developing test methodologies and procedures.
Works with Quality System on internal and external audits.
Assists with developing and validating methods.
Support and / or develop chemical testing procedures.
Coordinate Failure Investigations by designing and performing lab scale simulation of products made in the plant.
Troubleshoots & calibrates Lab equipment.
Assists with directing work of lab employees.