Temporary Product Safety and Surveillance Coordinator

AtriCure; Mason (OH); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical & Dental starting day 1

401K with match

Parental Leave

Volunteer Time Off

Pet Insurance

On-site fitness center and cafeteria

Job summary

AtriCure, Inc. is seeking a Product Safety and Surveillance Coordinator to communicate with field-based employees, distributors and customers regarding returns, RGAs and potential complaints.

This role will document and initiate necessary complaints in the quality system and monitor investigations. Responsibilities include coordinating with multiple teams, providing timely updates, and supporting compliance, risk management and regulatory functions.

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.)

Responsibilities

• Receive return requests from field staff, distributors and customers and issue return goods authorizations following company procedures.
• Monitor open RGAs and follow up periodically to promote prompt return of devices to AtriCure.
• Evaluate return goods requests and initiate complaints in the complaint management system and logs.
• Communicate with customers by telephone and email to gather information for complaint evaluations.
• Monitor complaint progress to ensure timely investigation completion.
• Assist in preparing ad-hoc and periodic complaint reports as requested by management.
• Support compliance activities such as procedure updates, training and internal audits.

Skills

Interpersonal skills

Phone communication

Email communication

Task prioritization

Education

High school diploma

Tools

Microsoft Office

Job description

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

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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AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits.

AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

You may access our global privacy policy here: https://www.atricure.com/privacy