Stability Testing
Stability Testing is a crucial process in medical device manufacturing where products are checked over time to ensure they remain safe and effective throughout their intended shelf life. It's like a long-term quality check that makes sure medical devices won't break down, lose their effectiveness, or become unsafe while they're being stored or used. This testing helps companies determine how long their products can be safely used and stored, which is essential information for hospitals, doctors, and patients. Similar terms include "shelf-life testing," "product stability analysis," or "accelerated aging studies."
Examples in Resumes
Managed Stability Testing programs for Class II medical devices, ensuring FDA compliance
Led Stability Study protocols for new product development
Conducted Stability Testing and Shelf Life Testing for surgical instruments
Typical job title: "Stability Testing Engineers"
Also try searching for:
Where to Find Stability Testing Engineers
Professional Organizations
Online Communities
Job Resources
Example Interview Questions
Senior Level Questions
Q: How would you design a stability testing program for a new medical device?
Expected Answer: A strong answer should cover planning test conditions, determining sample sizes, setting acceptance criteria, and ensuring compliance with FDA and ISO standards. They should mention risk assessment and how to handle unexpected results.
Q: How do you determine appropriate storage conditions for stability testing?
Expected Answer: The candidate should discuss how to evaluate environmental factors like temperature and humidity, explain real-time versus accelerated testing, and mention the importance of matching actual product storage conditions.
Mid Level Questions
Q: What factors do you consider when establishing a product's shelf life?
Expected Answer: Should discuss testing intervals, storage conditions, packaging materials, and how to analyze data to make reliable shelf-life predictions. Should mention documentation requirements.
Q: How do you handle out-of-specification results in stability testing?
Expected Answer: Should explain investigation procedures, documentation requirements, impact assessment on product safety, and when to involve regulatory authorities.
Junior Level Questions
Q: What is the difference between real-time and accelerated stability testing?
Expected Answer: Should explain that real-time testing occurs under normal storage conditions while accelerated testing uses stressed conditions to predict long-term stability more quickly.
Q: What basic documentation is required for stability testing?
Expected Answer: Should mention test protocols, data recording sheets, environmental monitoring records, and final reports. Should understand the importance of detailed record-keeping.
Experience Level Indicators
Junior (0-2 years)
- Basic testing procedures
- Documentation and record keeping
- Understanding of quality control basics
- Knowledge of lab safety procedures
Mid (2-5 years)
- Test protocol development
- Data analysis and trending
- Understanding of regulatory requirements
- Problem investigation skills
Senior (5+ years)
- Program design and management
- Risk assessment and mitigation
- Regulatory compliance expertise
- Team leadership and training
Red Flags to Watch For
- No knowledge of FDA or ISO requirements
- Lack of experience with documentation practices
- Unable to explain basic stability testing concepts
- No understanding of quality control principles
- Poor knowledge of medical device regulations
Related Terms
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