Position Summary: Coordinates, implements and maintains the Company's Document Control and Training System.
Primary Responsibilities and Functions:
Responsible for overall coordination of controlled documentation.
Performs document control function within the Company's Document Control system.
Reviews Engineering Change Orders for completeness, accuracy, and conformance to Standard Operating Procedures (SOP) and Work Instructions (WI).
Maintains history files and Quality records per applicable SOPs.
Implements Engineering Change Orders using word processing, graphics, and CAD software.
Maintains employee training files.
Assists in supporting external audits by ensuring timely response to documentation requests.
Organizes and ensures accurate and reliable filing systems for all paper-based documents.
A minimum of 2 to 4 years experience in basic configuration management in a manufacturing environment, preferably in the medical device industry
Must be able to create and edit Microsoft Office files (Word, Excel, PowerPoint, and Visio)
Basic working knowledge of cGMP (21CFR Part 820) and ISO 13485:2003 is highly desired.
Experience with an electronic document management system is a plus.
Knowledge of CAD software (SolidWorks preferred).
Knowledge of labeling software (Zebra preferred).
Additional Salary Information: We offer a comprehensive employee benefits package including paid time off, short and long term disability coverage, medical, dental, vision and life and accident insurance coverage and a 401(k) plan with Company match. There are no waiting periods and vesting in the 401(k) plan is immediate.
CardiacAssist, Inc. is a medical device company headquartered in the RIDC complex near Aspinwall, PA. We offer an array of products including the TandemHeart, an extracorporeal circulatory support system and the TandemLung oxygenator, which are used in hospitals across the U.S. and internationally. We employ engineers, technicians, product assemblers, marketing, customer service and support staff at our headquarters location and clinical/sales staff across the country.