Recruiter's Glossary

Examples: Process FMEA • Clean Room • GMP

ISO 13485

Term from Medical Device Manufacturing industry explained for recruiters

ISO 13485 is an important quality management standard that companies must follow when making medical devices. Think of it as a detailed rulebook that ensures medical products are consistently made safely and meet all necessary regulations. When someone mentions ISO 13485 on their resume, it means they understand how to work in an environment where product quality and patient safety are top priorities. This is different from the general manufacturing quality standard (ISO 9001) because it's specifically designed for medical devices, whether that's something as simple as a bandage or as complex as an MRI machine.

Examples in Resumes

Implemented ISO 13485 quality management system for medical device manufacturing facility

Led internal audits to maintain ISO 13485 certification

Trained production team on ISO 13485 compliance requirements and documentation

Typical job title: "Quality Managers"

Also try searching for:

Quality Assurance Manager Quality Control Manager Regulatory Affairs Manager Quality Systems Manager Medical Device Quality Engineer Quality Compliance Manager Quality Management Specialist

Where to Find Quality Managers

Professional Organizations

Online Communities

Job Boards

Example Interview Questions

Senior Level Questions

Q: How would you handle a major quality system failure that could affect product safety?

Expected Answer: Should demonstrate knowledge of corrective action procedures, risk management, and ability to lead crisis response while maintaining compliance with ISO 13485 requirements. Should mention documentation, investigation, and communication with regulatory bodies if necessary.

Q: How do you ensure your quality management system stays current with changing regulations?

Expected Answer: Should explain process for monitoring regulatory changes, implementing updates to procedures, training staff, and maintaining documentation. Should mention experience with internal audits and management reviews.

Mid Level Questions

Q: What is the difference between ISO 13485 and ISO 9001?

Expected Answer: Should explain that ISO 13485 is specifically for medical devices with stricter requirements for safety and documentation, while ISO 9001 is a general quality standard. Should mention specific medical device requirements like sterility and traceability.

Q: How do you maintain document control in a medical device company?

Expected Answer: Should discuss document approval processes, version control, training records, and how to ensure everyone uses current versions of procedures. Should mention electronic quality management systems.

Junior Level Questions

Q: What are the basic requirements of ISO 13485?

Expected Answer: Should mention key elements like document control, record keeping, product quality checks, and employee training. Basic understanding of quality management system structure is expected.

Q: How do you handle non-conforming products?

Expected Answer: Should describe basic process of identifying, segregating, and documenting non-conforming products. Should understand importance of investigating root causes.