Overview
Quality Engineer Jobs in Cincinnati, OH at Medasource
Title: Quality Engineer
Company: Medasource
Location: Cincinnati, OH
Job Title: Quality Engineer
Location: Onsite / Hybrid Columbus, OH
Client: Large Life Sciences Company
Start Date: ASAP
Duration: 1-year contractor with possibility of extension
Identify and create effective process control systems to support the development of the qualification deliverables.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving validation quality incidents.
Manage the quality validation activities of the workstream assigned.
Review and approve validation deliverables like: change records, DQ documents (SIA, URS, FRS, DS, TM, and FMEA and risk assessment), IQ, OQ, ES,PQ,PV,CV and variations.
Act as a liaison between Engineering, Div Quality Engineers, and Quality Systems, plant/division/Corporate, on all incidents or topics related to Pegasus validation systems of the workstream assigned.
Participate in or lead teams in supporting validation quality disciplines, decisions, and practices.
Escalate to the Validation Governance validation topics requiring clarification or further guidance.
Participate as an active member of the Validation Review Board (VRB).
Coach and guide the workstream team through the validation lifecycle phases of the Pegasus project.
Foster a culture of GOOD Engineering Practices (GEP), Food Safety, U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, and compliance standards, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
