Temporary Product Safety and Surveillance Coordinator

POSITION SUMMARY:

This position will communicate with field-based employees, distributors and customers by telephone, email and other means concerning returns, requests for servicing and possible complaints concerning AtriCure products.  He or she will initiate and communicate Return Goods Authorizations (RGAs), record them in the company’s systems, and conduct periodic review and follow-up to promote prompt return of the products.  The Product Safety and Surveillance Coordinator will further obtain information necessary to determine whether the return involves a product complaint and, if so, will initiate and process a complaint following the company’s quality system procedures, and periodically monitor the complaint to ensure timely completion.  The Product Safety and Surveillance Coordinator will ensure accurate and timely documentation of complaints and assist management in communicating with field-based employees, distributors and customers regarding the status of complaint investigations.

ESSENTIAL FUNCTIONS OF THE POSITION:

Receive return request from the field, distributors and customers, and issue return goods authorizations following company procedures

Monitor open RGAs and follow up periodically by telephone and/or email as necessary to promote the prompt return of devices to AtriCure

Evaluate return goods requests and initiate complaints in AtriCure’s complaint management system and applicable logs as appropriate

Communicate with customers and others by telephone and email to gather information needed for complaint evaluations, and record that information promptly and accurately in appropriate systems

Monitor complaint progress to ensure investigation completion in a timely manner.

Assist in preparing ad-hoc and periodic complaint reports, as requested by management

Support assigned compliance activities such as procedure updates, training, internal audits, etc.

Provide additional support to Compliance, Risk Management, Quality and/or Regulatory Affairs functions 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 required

Good interpersonal communications skills

Ability to prioritize tasks and complete work with minimal supervision

Computer/Data Entry Skills, working knowledge of Microsoft Office applications (Word, PowerPoint, Excel, Outlook, etc.)

PREFERRED QUALIFICATIONS:

Prior medical device complaint handling and/or product surveillance experience

Basic familiarity with medical device quality systems and regulations

Medical/clinical background or training

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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