ACIST Medical Systems is the market leader in providing innovative diagnostic and therapeutic products and services that enable interventionalists and their clinical teams in providing superior patient care. Our focus is “the pursuit of the perfect image” through continuous research and development of new products and technologies – supporting today’s needs and anticipate those of tomorrow. We are an international company, with products in over 45 countries, providing high quality systems and award-winning customer support across the globe.
We believe employees are our greatest asset. ACIST fosters an environment that attracts and retains employees who are proactive, responsive and innovative through commitment to teamwork, communication, feedback and change.
This position is responsible for administrating change control, document management, and employee training systems at Acist Medical Systems. Responsibilities include all aspects of Change Order processing, Device History Record filing and archiving, Technical Report administration and administration of the employee training system.
Primary Duties and Responsibilities:
Process change orders to ensure timely and accurate completion
Update Change Order and TR Database.
Distribute Documents to outside customers using the Document Distribution Database and Box™.
Enter/update parts in the Material Master of SAP
Enter/Update Bills of Materials in SAP and Print Bill of Material Reports.
“Approve” drawings in EPDM based on the written approval on Change Orders.
Update approved drawings in Solidworks.
Assure released documentation is appropriately filed(paper) and all documents sent to required external organizations and verified as received
Assure completion/closure of change order
File, scan and facilitate on-site and off-site storage of Device History Records and Technical Reports.
Administrate Technical Report process including issuing numbers, scanning, filing and printing monthly reports.
Manage Engineering Standards purchases and monthly updates, utilizing an outside Standards service
Update CTS training database and print training rosters
Other projects as assigned or required
Enter/activate and deactivate employees in the CTS database
Enter employee training requirements
Convert Microsoft quizzes to Mindflash format
Upload quizzes to Mindflash website
Invite required employees to take quizzes
Record completed training in CTS Database
Run reports as required from CTS system
High School diploma
2+ years working in an engineering change order environment, preferrably in the medical device industry
Working Knowledge of ISO 13485 and FDA Quality System Regulation
Microsoft Office experience
Strong interpersonal and communication skills
Strong computer user
Familiar with inventory MRP/ERP systems
Seeks information when something is not clear
Good attention to detail and understands importance of procedural compliance
Good organizational skills
4 + years experience in Medical Device Environment
Experience using SAP, EPDM, Solidworks, Microsoft Office, Box™, Mindflash.
Mental demands – work is detail oriented, often with multiple priorities. The environment is deadline sensitive and may be exposed to high-pressure situation
Travel requirements are minimal
Acist Medical Systems, Inc. - 12 months ago