Quality Coordinator

2 weeks ago


Charleston, United States CareerBuilder Full time

Mason HQ, 7555 Innovation Way, Mason, Ohio, United States of America

Req #2042
Tuesday, April 16, 2024
POSITION SUMMARY:
This position will be

responsible for ensuring the AtriCure Document Control System is in compliance with

domestic

and

international

medical

device

quality

system

regulations.

The

Quality

Coordinator

is

able

to answer daily quality questions to in regard to MasterControl and document control. In the role of the Quality Coordinator, this

person

will

work

with

the

entire

AtriCure

organization

to

ensure

compliance

with

the

AtriCure Quality System and will be responsible to report to management issues revolving around quality system compliance.
ESSENTIAL FUNCTIONS OF THE POSITION:
Responsible for processing Document Change Notices through the quality system
Responsible for processing Data Control and Engineering Protocols and Reports through the quality system
Responsible for Quality Systems Records filing, maintenance, and retention of all files (e.g. design history files, device history records, and other quality system records) per domestic and international regulatory requirements
Assisting with execution of updates of ERP system following release of Document Change Notices
Responsible for understanding and maintaining compliance with domestic and international medical device quality system regulations, where appropriate
Responsible for complying with all document control processes within the AtriCure Quality System.
Perform Quality System activities and other company activities in addition to the above as needed
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
Regular and predictable work performance
Ability to work under fast-paced conditions
Ability to make decisions and use good judgment
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned
BASIC QUALIFICATIONS:
High School Diploma or GED
Experience in recordkeeping and/or document management.
Strong computer/data entry and communication skills with an emphasis on attention to details
Problem solving/trouble shooting experience
PREFERRED QUALIFICATIONS:
Auditing Experience
Read technical Specifications
Read blueprints, drawings, specifications
Experience in a document management software such as Master Control
OTHER REQUIREMENTS:
Ability to regularly walk, sit, or stand as needed
Ability to occasionally bend and push/pull as needed
Ability to pass pre-employment drug screen and background check

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