Quality Control Laboratory Supervisor (Mentor, OH, US, 44060)

Steris Corporation•Mentor, OH

38d•$78,200 - $101,200

About The Position

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary The QC Laboratory Supervisor 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 all aspects of quality control within the organization including receiving, in-process, finished goods testing, scheduling resources, defining solutions to improve compliance, and provide key input to senior management on compliance in accordance with the requirements for ISO, FDA QSR, and STERIS policies.

Requirements

Bachelor degree
Minimum eight (8) years relevant lab testing in a regulated environment (i.e. FDA/ISO 13485).
Minimum two (2) years supervisory/leadership experience.
Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics.

Nice To Haves

Demonstrated experience with setting priorities and working with planning and scheduling teams in order to meet shipping goals.

Responsibilities

Supervises laboratory activities to ensure all products are tested in accordance with company policy and Good Laboratory Practices.
Supports NPD projects and completes all tasks related to the laboratory.
Serves as a contact point for outside vendors, consultants and auditors.
Assist with developing test methodologies and procedures.
Assists / trains Lab Techs and Specialist.
Works with QS on internal and external audits and audit training.
Assists with developing and validating methods.