Coordinate and lead activities supporting the successful 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.
Supplier Management: Manage supplier related processes including activities for qualification, audits, surveys, change control, corrective actions, and the approved supplier list (ASL).
Internal Audit Program: Schedule and perform internal quality audits, support the resolution of audit findings, and manage the resulting records and supporting evidence.
Batch Record Review / Product Disposition: Perform comprehensive Quality review of completed batch records and associated production records, including batch disposition decision-making.
Corrective and Preventive Action (CAPA): Support identification and resolution of events, perform root cause investigation, determine corrective action plans, carry out remediations, and drive 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, carry out remediations, and drive on time closure.
Documentation: Coordinate, manage, and perform quality review of controlled documents and records.
3rd Party Audits / Inspections: Participate in QMS audits of Cleveland Diagnostics by regulators, customers, Notified Body, or registrars (ISO certification and surveillance audits), and lead the remediation of audit findings.
Nonconforming Product: Assist all departments to identify, investigate, document, and resolve nonconformity events, products, and materials.
Change Control: Manage 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, coordinate refresher training, and present on quality related topics.
Complaint Files: Manage complaint records, perform root cause investigations, determine corrective action plans, and lead remediation activities.
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, product 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.
Position is on-site
Office environment with occasional visits to the laboratory or manufacturing areas.
- Supplier audits require occasional domestic and or international travel.
Primary activities are performed at a desk and include use of standard office equipment (computer, phone, photocopiers, filing cabinets, etc.).
May include periods of walking, standing, sitting, climbing stairs, and or light lifting.
Requires personal protective equipment (PPE) when visiting the manufacturing or laboratory areas.
Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples)
General office noise, HVAC and fluorescent lighting; offices reachable by elevator but should be able to climb stairs in case elevator out
Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.