Recruiter's Glossary

Examples: Process Validation • CER • Batch Release

FDA 21 CFR Part 820

Term from Medical Device Manufacturing industry explained for recruiters

FDA 21 CFR Part 820 is a set of quality control rules that medical device companies must follow in the United States. Think of it as a detailed rulebook that ensures medical devices are made safely and consistently. Companies need employees who understand these rules because following them is required by law. It's often called "Quality System Regulation" or "QSR" for short. When you see this on a resume, it means the person has experience working with medical device quality standards and regulations. This is similar to ISO 13485, which is the international version of these rules.

Examples in Resumes

Led quality team in maintaining FDA 21 CFR Part 820 compliance for Class II medical devices

Developed documentation system aligned with QSR requirements

Conducted internal audits to ensure 21 CFR Part 820 compliance

Trained production staff on Quality System Regulation procedures

Typical job title: "Quality Assurance Specialists"

Also try searching for:

Quality Manager Regulatory Affairs Specialist Quality Systems Engineer Quality Compliance Manager Medical Device Quality Engineer Quality Assurance Director Regulatory Compliance Specialist

Where to Find Quality Assurance Specialists

Professional Organizations

Online Communities

Job Boards

• MedTech Careers
• RAPS Job Board
• Medical Device Quality Jobs on LinkedIn

Example Interview Questions

Senior Level Questions

Q: How would you implement a quality system that meets FDA 21 CFR Part 820 requirements in a new medical device company?

Expected Answer: A senior candidate should be able to discuss creating a complete quality system, including document control, design controls, supplier management, and training programs. They should mention risk management and the importance of management responsibility.

Q: How do you handle a FDA inspection finding that reveals a major quality system issue?

Expected Answer: Should demonstrate knowledge of CAPA (Corrective and Preventive Action) processes, root cause analysis, and how to develop appropriate responses to FDA findings. Should emphasize documentation and follow-up verification.

Mid Level Questions

Q: What are the key components of a medical device quality system?

Expected Answer: Should identify major elements like document control, design controls, production controls, corrective actions, and management review. Should be able to explain how these components work together.

Q: Explain the difference between verification and validation in medical device quality.

Expected Answer: Should explain that verification confirms you built the product correctly (meets specifications), while validation confirms you built the right product (meets user needs). Should provide simple examples.

Junior Level Questions

Q: What is a quality record and why is it important?

Expected Answer: Should explain that quality records are documented evidence of activities affecting product quality, and they're required to show compliance with regulations. Should give basic examples like batch records or training records.

Q: What is document control and why is it necessary?

Expected Answer: Should describe basic concepts of controlling documents, including approval processes, revision control, and ensuring correct versions are used. Should understand why this is important for compliance.