What are the responsibilities and job description for the Quality Engineer position at Medasource?
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.
