DHR
DHR, which stands for Device History Record, is a crucial documentation system in medical device manufacturing. It's like a birth certificate for each medical device that tracks every step of how it was made. Companies must keep these records to prove they followed all the proper steps when making medical devices. This is required by regulatory agencies like the FDA to ensure product safety. When you see DHR mentioned in resumes or job descriptions, it usually refers to creating, maintaining, or reviewing these important manufacturing records.
Examples in Resumes
Managed DHR documentation for Class II medical devices, ensuring 100% compliance
Led team responsible for implementing electronic DHR system across 3 manufacturing sites
Reviewed and approved Device History Records for cardiovascular devices
Typical job title: "Quality Engineers"
Also try searching for:
Where to Find Quality Engineers
Professional Organizations
Online Communities
Job Resources
Example Interview Questions
Senior Level Questions
Q: How would you implement an electronic DHR system across multiple manufacturing sites?
Expected Answer: Should discuss change management, system validation, training programs, ensuring compliance across sites, and methods for maintaining data integrity while transitioning from paper to electronic systems.
Q: How do you handle DHR review discrepancies?
Expected Answer: Should explain investigation processes, corrective action procedures, documentation requirements, and how to maintain production while resolving quality issues.
Mid Level Questions
Q: What are the essential components of a DHR?
Expected Answer: Should mention production dates, quantities, inspection results, labeling copies, and any deviations from specifications, explaining why each is important for compliance.
Q: How do you ensure DHR compliance with FDA requirements?
Expected Answer: Should discuss regular audits, documentation procedures, training requirements, and maintaining current good manufacturing practices (cGMP).
Junior Level Questions
Q: What is a DHR and why is it important?
Expected Answer: Should explain that DHR tracks the production history of each device batch and is required for regulatory compliance and product traceability.
Q: How do you properly document a manufacturing deviation in a DHR?
Expected Answer: Should describe basic documentation requirements, including date, description of deviation, impact assessment, and proper approval processes.
Experience Level Indicators
Junior (0-2 years)
- Basic DHR review and documentation
- Understanding of medical device regulations
- Quality control inspection
- Basic GMP knowledge
Mid (2-5 years)
- DHR system maintenance
- Deviation investigation
- Quality system procedures
- Internal auditing
Senior (5+ years)
- Quality system implementation
- Regulatory compliance strategy
- Team management and training
- Process improvement
Red Flags to Watch For
- No knowledge of FDA requirements for medical device manufacturing
- Unfamiliarity with quality management systems
- Lack of attention to detail in documentation
- No experience with manufacturing processes
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