Job Summary
- Location
- Minneapolis, MN 55458
- Industries
- Medical Devices and Supplies
- Job Type
- Full Time
- Employee
- Career Level
- Experienced (Non-Manager)
- Job Reference Code
- 827
Quality Systems Technician
About the Job
It is MEDRAD's mission to be a worldwide market leader of medical devices and services that enable or enhance diagnostic and therapeutic imaging procedures. MEDRAD performance is a result of an unrelenting commitment to improving healthcare, to upholding standards of excellence, and to responsible activities for the benefit of our customers, shareholders, employees, and communities. These values are expressed through our culture and philosophy, as well as our ethical and corporate responsibility policies. MEDRAD has over 1,700 global employees, 1,200 of whom are in the Pittsburgh area. MEDRAD's European headquarters office is located in Maastricht, The Netherlands. Our Asian headquarters office is in Osaka, Japan with additional international offices located in France, Germany, Italy, China, UK, Brazil, Norway, Belgium, Sweden, Denmark, Singapore, Egypt, Mexico, Cyprus and Australia.
Position Description:
The Quality Systems Technician provides technical support for evaluation activities in support of quality assurance, returned products, microbiology, and manufacturing environments. Utilizes product quality principles and practices that ensure compliance to requirements in support of MEDRAD Interventional MN, Quality Systems. Additional responsibilities will include:
1. Evaluates performance of returned product from the field. Decontaminates bio-hazardous product upon receipt. Test product to determine failure mode and documents results.
2. Coordinates with engineering closing out returned product evaluation reports.
3. Conducts environmental monitoring and trending in controlled environment and white rooms per documented requirements.
4. Performs table top, HEPA filter particle counts, monitors temp and humidity in controlled environments and white rooms. Works with Facilities and Microbiology departments to ensure controlled environment meets specifications.
5. Monitors the in-house DI/UF water system. Performs daily maintenance check on the system.
6. Collects, organizes and summarizes test data into clearly understood format. Uses basic statistical methods to describe data, trend processes and/or experimental data.
7. Presents data effectively using appropriate format – spreadsheet / report.
Technical & Behavioral Requirements:
1. High school diploma required
2. Two (2) years experience in the medical device industry is required
3. Two (2) years experience with current Good Manufacturing Practices, Quality System Requirements, applicable ISO quality system standards and the EU Medical Device Directive is required
4. Three (3) years experience with software programs including Microsoft Word, Matrix, Excel, PowerPoint, PLM, MRP and complaint software is required
5. Two (2) years of analytical and interpretive skills to apply regulations to our products is required
6. Strong competency in Customer Focus, Driving for Results, Integrity and Trust, Ethics and Values and Compassion.
7. Proven ability to demonstrate at minimum, MEDRAD’s Team Contributor competencies: Action Oriented, Perseverance, Dealing with Ambiguity, Learning on the fly and Problem Solving.
To Apply Visit MEDRAD, Inc.
Position Description:
The Quality Systems Technician provides technical support for evaluation activities in support of quality assurance, returned products, microbiology, and manufacturing environments. Utilizes product quality principles and practices that ensure compliance to requirements in support of MEDRAD Interventional MN, Quality Systems. Additional responsibilities will include:
1. Evaluates performance of returned product from the field. Decontaminates bio-hazardous product upon receipt. Test product to determine failure mode and documents results.
2. Coordinates with engineering closing out returned product evaluation reports.
3. Conducts environmental monitoring and trending in controlled environment and white rooms per documented requirements.
4. Performs table top, HEPA filter particle counts, monitors temp and humidity in controlled environments and white rooms. Works with Facilities and Microbiology departments to ensure controlled environment meets specifications.
5. Monitors the in-house DI/UF water system. Performs daily maintenance check on the system.
6. Collects, organizes and summarizes test data into clearly understood format. Uses basic statistical methods to describe data, trend processes and/or experimental data.
7. Presents data effectively using appropriate format – spreadsheet / report.
Technical & Behavioral Requirements:
1. High school diploma required
2. Two (2) years experience in the medical device industry is required
3. Two (2) years experience with current Good Manufacturing Practices, Quality System Requirements, applicable ISO quality system standards and the EU Medical Device Directive is required
4. Three (3) years experience with software programs including Microsoft Word, Matrix, Excel, PowerPoint, PLM, MRP and complaint software is required
5. Two (2) years of analytical and interpretive skills to apply regulations to our products is required
6. Strong competency in Customer Focus, Driving for Results, Integrity and Trust, Ethics and Values and Compassion.
7. Proven ability to demonstrate at minimum, MEDRAD’s Team Contributor competencies: Action Oriented, Perseverance, Dealing with Ambiguity, Learning on the fly and Problem Solving.
To Apply Visit MEDRAD, Inc.
