Duration: 6 months with possible extension
Location: : Colorado Springs, CO 80921
You will be responsible for visual and dimensional inspections, as defined by standard operating procedures, and engineering drawings. You will be required to perform inspections to determine accept /reject disposition based on your inspection results. Your role will also be required to work well in a team environment promoting our Company Shared Values.
What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with a great team of dedicated experts and leaders in the Medical Device Industry who will support your continued growth. You will learn from your fellow Engineers, Clinicians, Sales Leaders, and other industry professionals about our state of the art products.
What You Will Become: A highly influential driver who will be key in helping achieve our mission of delivering consistent high quality, safe and effective, regulatory compliant products and services.
What Success Looks Like:
• Full responsibility for focusing on accuracy and detail to meet company quality standards
• Utilize standard operating procedures, and drawings, to perform quality inspections on all extrusions
• Complete 100% inspection and maintain accurate accept/reject data
• Utilize various measuring equipment and collect data to determine component acceptance
• Generate and apply material accepted labels for accepted components
• Review DHRs and LHRs for good documentation practices and administrative errors
• Interface with engineering, quality, and production/extrusion teammates to communicate quality standards and address issues in a timely manner
• Working in cleanroom environment while performing consumable product inspections
• Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• High School diploma or equivalent
• Minimum 1-2 years experience in medical, electrical, or mechanical Quality Control Inspection or SPNC Manufacturing
• Knowledge and operation of precision testing equipment and tools
• Ability to lift and work with parts or sub-assemblies weighing up to 50 pounds
• Computer abilities with web based systems
• Cleanroom environment experience (Preferred)
• Government regulated environment experience such as FDA or ISO (Preferred)