Senior Quality Specialist — Onsite QA Leader

Cleveland Diagnostics, Inc.; Cleveland (OH); On-site; USD 75,000 - 100,000; Full time

Benefits offered by this job

100% Employer‑paid medical for single

Employer match 4% retirement

Paid Family Leave Program

Flexible work schedule

Office convenient location

Free coffee, snacks

Job summary

Cleveland Diagnostics, Inc. is seeking a Senior Quality Specialist to sustain and improve the Quality Management System in a regulated environment. This onsite role in Cleveland, OH collaborates with the Head of Quality Assurance to ensure compliance with ISO13485, EU IVDR, and 21 CFR 820.

You will manage supplier processes, internal audits, CAPA, documentation, and change control while driving continuous improvement and training across the organization.

Qualifications

• Bachelor’s degree in a scientific field such as chemistry, biology, or engineering.
• 8+ years of quality experience in FDA-regulated industry (medical device/pharma).
• Strong knowledge of QMS (21 CFR 820, ISO 13485, EU IVDR) and cGMP/GDocP.
• Excellent verbal and written communication skills.
• Proficient with Microsoft Office.

Responsibilities

• Coordinate and lead QMS maintenance per ISO13485, EU IVDR, 21 CFR 820.
• Create, review, manage QMS documentation.
• Conduct internal quality audits and manage audit findings.
• Perform batch record review and product disposition decisions.
• Support CAPA, deviation investigations, root cause analysis.
• Manage change control and supplier related processes.
• Coordinate QMS training for new hires.
• Participate in 3rd party audits/inspections.

Skills

Attention to detail

Critical thinking

Risk-based decision making

Communication skills

Quality mindset

Team collaboration

Education

Bachelor’s degree in science or engineering

Tools

Microsoft Office

QMS software

Job description

Cleveland Diagnostics, Inc. is seeking a Senior Quality Specialist to sustain and improve the Quality Management System in a regulated environment. This onsite role in Cleveland, OH collaborates with the Head of Quality Assurance to ensure compliance with ISO13485, EU IVDR, and 21 CFR 820.

You will manage supplier processes, internal audits, CAPA, documentation, and change control while driving continuous improvement and training across the organization.