Quality Specialist

Quality Specialist

Participate in activities supporting the successful implementation and maintenance of the quality management system (QMS) in compliance with current ISO13485, EU IVDR, and 21 CFR 820 requirements. Create, review, and manage documentation related to the QMS. Participate in cGMP and quality related activities. Requires excellent attention to detail, critical thinking, risk-based decision making, communication, and a consistent quality minded approach.

Essential Duties & Responsibilities:

• Support the supplier management process including related activities for qualification, audits, surveys, change control, corrective actions, and the approved supplier list (ASL).
• Schedule and perform internal quality audits, assist in the resolution of audit findings, and manage the resulting records and supporting evidence.
• Perform comprehensive Quality review of completed batch records and associated production records.
• Support identification and resolution of events, perform root cause investigation, determine corrective action plans, and facilitate on time closure.
• 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.
• Coordinate, manage, and perform quality review of controlled documents and records.
• Participate in QMS audits of Cleveland Diagnostics by regulators, customers, Notified Bodies, or registrars (ISO certification and surveillance audits).
• Assist all departments to identify, investigate, document, and resolve nonconformity events.
• 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.
• Coordinate initial QMS training for new hires, assist all departments to manage employee training, and coordinate refresher training.
• Support complaint records, perform root cause investigations, and determine corrective action plans.
• Support information gathering and analysis for the QMS management review process.
• Perform Quality checks of manufacturing activities including label verification, final release inspection, and records review.
• 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

Working Relationships:

• Interacts frequently with employees across and at all levels within the organization
• Collaboration expected to resolve identified issues and events
• Participates in cross-functional teams
• Does not have direct reports

Work Environment / Physical Requirements:

• Bachelor's degree in a scientific discipline such as chemistry, biology, or engineering
• ? 4 years of experience in a Quality role within a US FDA regulated industry such as medical device or pharmaceutical manufacturing
• Working knowledge and experience with Quality Management Systems (QMS) such as 21 CFR 820, ISO13485, or EU IVDR
• Working knowledge and experience with current good manufacturing practices (cGMP) and good documentation practices (GDocP)
• Excellent verbal and written communication skills
• Excellent computer proficiency with Microsoft Office products
• General office and HVAC noise