Senior Quality Specialist

Cleveland Diagnostics; 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

Our team is growing, and we currently have an immediate opening for a SeniorQuality Specialist

Title

Senior Quality Specialist

Location

Onsite-Cleveland Office

Reports To

Head of Quality Assurance

Job Overview

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.

Working Relationships

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

Preferred Skills, Education, and Experience:

• Bachelor’s degree in a scientific discipline such as chemistry, biology, or engineering.
• ≥ 8 years of experience in a Quality role within a US FDA regulated industry such as medical device or pharmaceutical manufacturing.
• Extensive knowledge and experience with Quality Management Systems (QMS) such as 21 CFR 820, ISO13485, or EU IVDR.
• Extensive 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.

Work Environment / Physical Requirements:

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.

Cleveland Diagnostics, Inc., is developing highly efficacious, lab‑friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. We pride ourselves in fostering a family‑focused, friendly, and flexible organization that places our employee’s well‑being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

• 100% Employer‑paid medical for single coverage effective on your date of hire and 50% employer‑paid medical for spouse/dependent coverage
• No cost for employee coverage for Group Term Life, Short & Long Term Disability
• 4% retirement contribution Employer match
• Paid Family Leave Program
• Flexible work schedule & lucrative employee referral program
• Salary range may vary by work state/geographical region/territory
• Easy to get to office location with newly built‑out office space
• Free coffee, snacks and other goodies all day long

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities. All employment decisions without regard to race, creed, religion, color, national origin, and ancestry, known or perceived mental or physical disability, age, marital or familial status, pregnancy or related medical conditions, sex/gender (including pregnancy/childbirth, sexual orientation and gender identity or expression), transgender status, domestic violence or sexual assault victim status genetic information, military or veteran status, or any other status protected under applicable federal, state, or local laws. This policy applies to all terms and conditions of employment, including but not limited to: recruiting, hiring, placement, promotion, assignment of duties, termination, layoff, recall, transfer, leaves of absence, benefits, compensation and training. The Company seeks to comply with all applicable federal, state and local laws where we operate.

Required Applicant Posters and Links Family & Medical Leave Act Employee Polygraph Protection Equal Employment Opportunity Right to Work E-Verify Machine Readable Files for Anthem Healthcare Plans 2026 (FEIN: 46-3916837)

Pay Range: $75,000 - $100,000 per year