Posted on Monday, April 07, 2008
Senior Quality Engineer - Colorado Springs

Company Profile:

Spectranetics Corporation engages in the development, manufacture, marketing, and distribution of single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in the United States, Europe and Japan. Spectranetics Corporation was founded in 1984 and is based in Colorado Springs, Colorado.

Job Summary:

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet requirements established by Spectranetics, customers and regulatory agencies. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives. Provides focused quality engineering support within new product development.
Maintains Risk Management documentation and provides Quality Engineering support for the life cycle of all Spectranetics products.

Education/Preferred Experience:

• BS in Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline.
• Strong and solid experience in Risk Management for medical devices
• Application and leading problem-solving, root cause analysis and related Corrective and Preventive Action (including verification)
• Experience with Health Hazard Analysis
• Familiarity with ISO 14971
• Medical devices engineering

Job Duties:

• Provide QA leadership to project and system for the fill lifecycle of the product, service or system
• Develop, update and maintain SOPs, forms, methods related to Quality in the NPI/DC SOP and Risk Management system
• Ensure Risk Management is effective utilizing feedback from validation, field safety, manufacturing indicators, CAPAs, HHAs, ect.
• Lead and support Health Hazard Analysis to ensure risk assessment and root cause analysis across products and systems.

Pleas submit resume to: julianne.mashke@spectranetics.com

# posted by ASQ St. Louis @ Monday, April 07, 2008