Quality Technician

Summary of Function:

The Quality Technician (QT) is responsible for the inspection and release activities for all manufactured products. The QT will assist with activities that support the manufacturing of components and finished goods.  A Quality Technician typically works independently with minimal guidance from other lab staff necessary and is able to provide leadership, guidance, and training to less senior members of the lab staff.

Major Duties and Responsibilities:

1. Perform sample-based inspections to meet requirements for:
   • Start-up
   • Receiving
   • Final
   • Qualification Start-ups/Samples
   • Last 4 Shot
2. Assist with daily containment activities, root cause analysis, and corrective action as requested.
3. Assist in setting lab priorities and division of responsibilities
4. Complete documentation (batch record) review related to FDA regulated medical devices and components as outlined in “product release” planning sheets
5. Execute and document First Article Inspection Reports (FAIR), Change in Manufacturing Methods (CIMM) inspections, Qualifications of new molds, and any other requested inspections.
6. Perform CER particle testing
7. Develop relationships with other departments with the goal of instructing and communicating quality requirements
8. Completion of all required documentation, legibly and accurately on paper and electronically in computer systems
9. Inspection and review of production and quality documentation for accuracy and conformance
10. Use, maintain, and store quality assurance equipment and instruments properly
11. Create and participate in Gage R&R and process capability studies
12. Train quality inspectors
13. Consistently notices/identifies trends and outliers in data
14. Develop simple routines on vision equipment (SmartScope, Keyence, etc.)
15. Create material certifications for shipment
16. Calibrate equipment and complete associated documentation
17. Properly file all documentation and samples
18. Communicate effectively with other shifts at shift change on a daily basis
19. Maintain a professional relationship with all other employees
20. Keep a clean and orderly work area
21. Work to achieve Monthly Company goals and metrics
22. Runs lab without other inspector support
23. Participate in internal audits
24. Perform other tasks assigned by the Quality Lab Supervisor and/or Quality Manager
25. Support and adhere to Medbio’s Corporate Mission and Core Values

 Organizational Relationships:

The Quality Technician reports to the Quality Lab Supervisor for technical direction and training. The Quality Technician interacts with management, engineers, maintenance, operators, and assemblers to resolve product or process-related issues.

 Experience and/or Educational Requirements:

1. High school diploma or GED equivalent required.
2. 2-5 years’ experience in quality assurance required
3. Strong written/verbal communication, leadership, interpersonal and motivational skills
4. Basic computer skills (Microsoft Office)
5. Moderate problem-solving skills
6. Moderate math skills, including geometry
7. Moderate blueprint reading skills preferred, training provided
8. Advanced measuring skills
9. Moderate grammar skills

 Physical Requirements:

• Must be able to work a standard 40-hour workweek, with occasional overtime including days outside of set schedule.
• Sitting and/or standing for extended periods of time as well as some walking within the facility.
• Must be able to have 20/20 vision with or without corrective lenses and distinguish color differences and depth perception for product and safety issues.
• Hearing ability should be sufficient to hear and react to audible alarms from distances up to 100 feet.
• Must be able to lift and carry various items up to 30 pounds.
• Pass an audiology screening

Quality Technician ($21.00-23.00/hr.)