Temporary Product Safety and Surveillance Coordinator

AtriCure; Mason (OH); On-site; USD 52,000 - 70,000; Full time

Benefits offered by this job

Medical & Dental beginning day 1

401K with match

30 days of parental leave

Volunteer Time off

Pet Insurance

On-site fitness center

On-site cafeteria

Job summary

AtriCure, Inc. is seeking a Temporary Product Safety and Surveillance Coordinator in Mason, OH. The role focuses on returns, servicing requests, and potential complaints, initiating RGAs, and documenting activity in the quality system.

You will manage communications with field teams, distributors, and customers to ensure timely resolution of issues. Primary duties include evaluating return requests, initiating complaints when needed, and maintaining accurate records while supporting compliance

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 and issue return goods authorizations following procedures.
• Monitor open RGAs and follow up to promote prompt return of devices.
• Evaluate return goods requests and initiate complaints in the management system.
• Gather information by phone/email for complaint evaluations and document in systems.
• Monitor complaint progress to ensure timely investigation completion.
• Assist in preparing ad-hoc and periodic complaint reports for management.
• Support assigned compliance activities and internal audits as needed.
• Provide additional support to Compliance, Risk Management, Quality and Regulatory affairs functions.

Skills

Interpersonal communication

Task prioritization

Data entry

Microsoft Office

Education

High school diploma

Tools

Microsoft Office Suite

Job description

Temporary Product Safety and Surveillance Coordinator

Mason, OH

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 othersAdditional 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

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).

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in AtriCure’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

By checking this box, I agree to allow AtriCure to retain my data for future opportunities for employment for up to 730 days after the conclusion of consideration of my current application for employment.

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