Temporary Product Safety and Surveillance Coordinator
AtriCure · Mason, OH, United States
About The Role
<div class="content-intro"><p style="margin: 0in; text-align: justify; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-size: 10.0pt; font-family: Arial, sans-serif;">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.</span></p>
<p style="margin: 0in; text-align: justify; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"> </p>
<p style="margin: 0in; text-align: justify; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-size: 10.0pt; font-family: Arial, sans-serif;">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.</span></p></div><p><span data-contrast="none">POSITION SUMMARY:</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<p><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<p><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<p><span data-contrast="none">ESSENTIAL FUNCTIONS OF THE POSITION:</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Receive return request from the field, distributors and customers, and issue return goods authorizations following company procedures</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Monitor open RGAs and follow up periodically by telephone and/or email as necessary to promote the prompt return of devices to AtriCure</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Evaluate return goods requests and initiate complaints in AtriCure’s complaint management system and applicable logs as appropriate</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">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</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Monitor complaint progress to ensure investigation completion in a timely manner.  </span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Assist in preparing ad-hoc and periodic complaint reports, as requested by management</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Support assigned compliance activities such as procedure updates, training, internal audits, etc.</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">Provide additional support to Compliance, Risk Management, Quality and/or Regulatory Affairs functions as needed</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<p><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<p><span data-contrast="none">ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">Regular and predictable work performance </span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="none">Ability to work under fast-paced conditions</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="none">Ability to make decisions and use good judgment</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="none">Ability to prioritize various duties and multitask as required</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="none">Ability to successfully work with others</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="43" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Additional duties as assigned </span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<p><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<p><span data-contrast="none">BASIC QUALIFICATIONS:</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1"><span data-contrast="none">High school diploma required</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="15" data-aria-level="1"><span data-contrast="none">Good interpersonal communications skills</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="16" data-aria-level="1"><span data-contrast="none">Ability to prioritize tasks and complete work with minimal supervision</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="17" data-aria-level="1"><span data-contrast="none">Computer/Data Entry Skills, working knowledge of Microsoft Office applications (Word, PowerPoint, Excel, Outlook, etc.)</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<p><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<p><span data-contrast="none">PREFERRED QUALIFICATIONS:</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="43" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Prior medical device complaint handling and/or product surveillance experience</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="43" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Basic familiarity with medical device quality systems and regulations</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="43" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Medical/clinical background or training</span><span data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<p><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<p><span data-contrast="none">OTHER REQUIREMENTS:</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":270,"335559737":414,"335559738":0,"335559740":240}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="18" data-aria-level="1"><span data-contrast="none">Ability to regularly walk, sit, or stand as needed</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="19" data-aria-level="1"><span data-contrast="none">Ability to occasionally bend and push/pull as needed</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="44" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="20" data-aria-level="1"><span data-contrast="none">Ability to pass pre-employment drug screen and background check</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335557856":16777215,"335559685":540,"335559737":414,"335559738":0,"335559740":240,"335559991":180}"> <br><br><br>#LI-JS1<br>#INDPR<br></span></li>
</ul><div class="content-conclusion"><p><span style="font-size: 10.0pt; font-family: Arial, sans-serif;">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: <a href="https://www.atricure.com/careers-atricure/benefits">https://www.atricure.com/careers-atricure/benefits</a>. </span></p>
<p><span style="font-size: 10.0pt; font-family: Arial, sans-serif;">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).</span></p>
<p><span style="font-size: 10.0pt; font-family: Arial, sans-serif;">You may access our global privacy policy here: <a href="https://www.atricure.com/privacy">https://www.atricure.com/privacy</a> </span></p></div>
Similar roles you might like
See all →This is an external listing. JobSpring does not represent or verify the employer. Report this listing