Documentation Control Specialist
Acist Medical Systems, Inc. - Eden Prairie, MN

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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.

Position Summary:
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:
Document Management

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

Employee Training

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

Required Skills

Minimum

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

Preferred

4 + years experience in Medical Device Environment

Experience using SAP, EPDM, Solidworks, Microsoft Office, Box™, Mindflash.

Other

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

Required Experience

Acist Medical Systems, Inc. - 23 months ago - save job - copy to clipboard
About this company
ACIST® Medical Systems is a global medical device company that develops advanced contrast injection technologies that help simplify the...