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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