Quality Specialist

Description

The QC Specialist organizes and runs the routine analysis of the Quality Control Department. This role is crucial in ensuring the Quality Control Department meets the efficiency goals while satisfying customers. This individual is responsible for conducting inspection and testing procedures during manufacturing processes and receiving inspection processes to ensure the products comply with requirements.

Technical Expertise: KEYENCE INSPECTION

Requirements

1. ASQ certification and at least 5 years of medical device experience
2. Ability to ensure organization and prioritization in order to meet production goals and deadlines
3. Excellent written and verbal communication skills and attention to detail
4. Ability to problem solve and maintain critical thinking
5. Sound understanding of the concepts and principle of inspection techniques and methods. Knowledge and understanding of geometric dimensioning and tolerance. Ability to interpret engineering drawings and handle various types of measuring instruments such as micrometers, calipers, optical comparators and vision system measuring machines (Keyence).
6. Ability to multi-task and complete essential responsibilities with minimal oversight
7. Highly motivated to initiate projects and drive to execute through completion
8. Data Analysis, reports writing, and business correspondence
9. Computer Skills - word, excel, Power Point, knowledge of basic ERP systems
10. Knowledge of FDA Good Manufacturing Practices and general understanding of Quality System Regulations and International QMS standards (ISO)
11. Advanced GD&T
12. Assist with special projects from Management
13. Perform inspections across all stages of production
14. Training employees on procedures, use of equipment, production techniques and method development as demonstrated by Manager
15. Evaluate data and draft reports, noting any relevant deviations from existing standards
16. Maintain flow of QC samples and delegate necessary tasks to ensure deadlines are met
17. Coordinate and support first article inspection and validation activities
18. Communicate quality or compliance with urgency
19. Responsible for PM activities
20. Other duties as assigned