QMS
QMS (Quality Management System) is a formal system that documents processes, procedures, and responsibilities for achieving quality policies and objectives in medical device manufacturing. Think of it as a comprehensive rulebook that ensures medical devices are consistently made safely and effectively. Companies use QMS to track everything from design to delivery, making sure products meet FDA and other regulatory requirements. Similar terms you might see include ISO 13485 (the international standard for medical device QMS) or Quality System. It's like having a detailed instruction manual that everyone in the company follows to maintain product quality and safety.
Examples in Resumes
Implemented and maintained QMS compliance for Class II medical devices
Led internal audits of Quality Management System processes
Developed QMS documentation and trained staff on quality procedures
Typical job title: "Quality Management Specialists"
Also try searching for:
Where to Find Quality Management Specialists
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 discuss systematic approach to investigation, corrective actions, preventive measures, and importance of documentation and communication with regulatory bodies when necessary. Should emphasize patient safety and compliance requirements.
Q: How do you ensure QMS effectiveness across multiple manufacturing sites?
Expected Answer: Should explain strategies for standardization, training programs, audit schedules, and methods to maintain consistent quality across different locations while adapting to local requirements.
Mid Level Questions
Q: What is your experience with internal quality audits?
Expected Answer: Should describe experience planning and conducting audits, documenting findings, tracking corrective actions, and ensuring follow-up on identified issues.
Q: How do you handle document control in a QMS?
Expected Answer: Should explain process for creating, reviewing, approving, and maintaining quality documents, including version control and training requirements.
Junior Level Questions
Q: What are the basic elements of a Quality Management System?
Expected Answer: Should mention key components like document control, record keeping, training requirements, change control, and basic quality procedures.
Q: How do you write a Standard Operating Procedure (SOP)?
Expected Answer: Should describe basic format, necessary elements, approval process, and importance of clear, concise instructions.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of quality procedures
- Document control
- Data entry and record keeping
- Following SOPs
Mid (2-5 years)
- Internal auditing
- CAPA management
- Training coordination
- Quality documentation writing
Senior (5+ years)
- FDA and ISO compliance management
- Quality system implementation
- Regulatory submission preparation
- Team leadership and project management
Red Flags to Watch For
- No knowledge of FDA regulations or ISO standards
- Lack of attention to detail in documentation
- Poor understanding of risk management
- No experience with corrective and preventive actions (CAPA)
Related Terms
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