A leading medical device company is seeking a ECO Document Specialist to assist with product release activities, process controls and facility compliance.

Responsibilities:

• Customer Acceptance (CA) testing and Commissioning of finished medical devices and analytical instruments manufactured and repaired onsite.
• Generating and organizing Device History Records (DHRs), along with other testing/product release paperwork.
• Incoming inspection, acceptance/rejection of parts and components used for production.
• Communicating with vendors to obtain compliance files as necessary.
• Coordinate/manage calibrations and preventative maintenance of controlled equipment.
• Undertake regular facility control checks to ensure Good Manufacturing Practice (GMP).
• Perform basic data reporting/analysis and trending on product and process performance.
• Participate in audits and inspections with the Notified Bodies and Regulatory authorities for ISO and QSR compliance, acting as the sites SME for QA/QC.
• Input into ITL's Quality Management System (QMS) and site specific Standard Operating Procedures (SOPs).
• Implementation of ITL's QMS SOPs for Design and Development into the Virginia Site.

Qualifications/Preferred Experience:

• Must possess at a minimum, a Bachelor's Degree in an Engineering, Manufacturing or Repair Technologies field of study, or similar technical discipline, as well as 3 to 5 years industry experience working in a QA/QC role within a manufacturing type environment.
• Experience working and implementing compliant SOPs to ISO 13485, ISO 9001 and 21 CFR Part 820 is a must.
• A capacity to work with basic engineering drawings, manufacturing and test procedures, along with inspection, measuring and test equipment, is required.
• Direct experience working with Medical Devices or electromechanical instrumentation is required.
• The Ability to work independently, with a strong commitment to customer satisfaction.
• Experience with Medical Device Risk Management (ISO 14971) is a plus.