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Cleveland Diagnostics · 1 day ago

Quality Specialist

Cleveland, OH

Full-time

Onsite

Mid Level

$60K/yr - $90K/yr

4+ years exp

Cleveland Diagnostics is developing affordable diagnostics tests to improve cancer diagnostics. They are seeking a Quality Specialist to support the implementation and maintenance of the quality management system (QMS) in compliance with relevant regulations and standards.

BiotechnologyHealth CareHealth DiagnosticsNeuroscience

Responsibilities

Supplier Management: Support the supplier management process including related activities for qualification, audits, surveys, change control, corrective actions, and the approved supplier list (ASL)

Internal Audit Program: Schedule and perform internal quality audits, assist in the resolution of audit findings, and manage the resulting records and supporting evidence

Batch Record Review: Perform comprehensive Quality review of completed batch records and associated production records

Corrective and Preventive Action (CAPA): Support identification and resolution of events, perform root cause investigation, determine corrective action plans, and facilitate on time closure

Deviations: Support identification and resolution of events, perform risk and impact assessment, implement immediate corrections, perform root cause investigation, determine corrective action plans, and facilitate on time closure

Documentation: Coordinate, manage, and perform quality review of controlled documents and records

3rd Party Audits: Participate in QMS audits of Cleveland Diagnostics by regulators, customers, Notified Bodies, or registrars (ISO certification and surveillance audits)

Nonconforming Product: Assist all departments to identify, investigate, document, and resolve nonconformity events

Change Control: Support the change control process to determine and address the potential risks and impact of changes to product design, materials, processes, systems, equipment, etc. This includes the management of associated records and supporting documentation

Training: Coordinate initial QMS training for new hires, assist all departments to manage employee training, and coordinate refresher training

Complaint Files: Support complaint records, perform root cause investigations, and determine corrective action plans

Quality Management Review: Support information gathering and analysis for the QMS management review process

Quality Oversight: Perform Quality checks of manufacturing activities including label verification, final release inspection, and records review

Continuous Improvement: Participate in the creation, revision, and implementation of procedures, forms, and work instructions to improve current processes

Prepare for and participate in QA-related activities

All other duties as assigned

Qualification

Quality Management SystemsISO1348521 CFR 820CGMPQuality AuditsRoot Cause InvestigationMicrosoft OfficeCommunication SkillsAttention to DetailCritical Thinking