Supervisor, Post Market Surveillance

<p style="text-align:inherit"></p><p style="text-align:left"><b>Why Merit?</b></p><p style="text-align:inherit"></p><p style="text-align:left">At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>WORK SHIFT</b></p>DAY (United States of America)<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>SUMMARY OF DUTIES</b></p>Supervises and is responsible for complaint intake, receiving, complaint coordination, and complaint closures. Works with internal and external customers to ensure proper handling and documentation of reported complaints. Works closely with the Clinical Quality team to ensure on time reporting of complaints to regulatory authorities (when applicable).<p style="text-align:inherit"></p><p style="text-align:inherit"></p><div><h3>ESSENTIAL FUNCTIONS <span>PERFORMED</span></h3><p></p><p>Ensures that company procedures (GP, GPS, QSP, etc.) and regulatory standards (FDA, CFR, MDR, ISO, etc.) are followed with respect to assigned areas of responsibility.</p><p>Supervises Quality and Field Assurance technicians by interviewing, training, evaluating job performance, discipling, scheduling work and other related responsibilities.</p><p>Works<span> closely </span>with Sales Representatives and customers to clarify, obtain, and/or better understand the reported information in relation to product complaints.</p><p>Performs follow-up in the form of emails or calls to obtain additional <span>information relating to product complaints.</span></p><p>Provides training to employees on Merit’s complaint handling process<span>.</span></p><p>Establish relationships and builds confidence among staff, physicians, Sales Representatives, and other <span>customers.</span></p><p>Ensures customer complaints are well <span>documented and compliant with applicable regulatory standards.</span></p><p>Responsible for Corrective Preventive Actions (CAPA)<span>; including investigations</span> and resolving issues and determining course of action.</p><p>Responsible for complaint associated product receipts and product decontamination.</p><p><span>Leads Complaint Review Board. </span></p><p>Establishes and maintains metrics for complaint closure timeliness, complaint initiation timeliness, and any other business metric need around complaint handling.</p><p>Identifies and records any product, process and quality system<span> problems.</span></p><p><span>Acts as the Subject Matter Expert on complaint handling and Merit’s process for internal/external audits.</span></p><p>Makes presentations at and/or attends local, regional, and national meetings requiring complaint handling expertise, knowledge, and <span>experience.</span></p><p><span>Escalates to the Sr. Manager of Global Complaint Handling if problems arise. </span></p></div><p>Performs other duties and tasks as <span>required.</span></p><div><p></p><h3><span>ESSENTIAL</span> <span>PHYSICAL/ENVIRONMENTAL</span> <span>DEMANDS</span></h3><ul><li>Lifting -- Not to exceed 50 lbs. – local practice may <span>apply.</span></li><li><span>Writing</span></li><li><span>Sitting</span></li><li><span>Standing</span></li><li><span>Bending</span></li><li>Visual <span>acuity</span></li><li>Color <span>perception</span></li><li>Depth <span>perception</span></li><li><span>Reading</span></li><li>Field of <span>vision/peripheral</span></li></ul><p></p><h3>SUMMARY OF MINIMUM <span>QUALIFICATIONS</span></h3><ul><li>Education and/or experience equivalent to a Bachelor&#39;s degree in a related field.</li><li>A thorough understanding of customer service <span>practices.</span></li><li><span>Demonstrated experience </span>applying analytical and problem solving skills to understand and solve complex <span>issues.</span></li><li>Ability to train employees</li><li>Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software <span>programs.</span></li><li>Knowledge of NC/CAPA causes/corrective actions/dispositions</li></ul><h3></h3><h3>PREFERRED <span>QUALIFICATIONS</span></h3><ul><li>Knowledge of medical product/device <span>use.</span></li></ul><p></p><h3><span>COMPETENCIES</span></h3><ul><li><span>Interpersonal skills</span></li><li><span>Written and verbal communication</span></li><li><span>Organizational</span> <span>skills</span></li><li><span>Staff Training</span></li><li>Problem <span>solving</span></li><li>Project supervision</li></ul></div><p></p><h3><span>COMMENTS</span></h3><p></p><p>Infectious Control Risk Category <span>I:</span></p><p></p><p>The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category I states employment and procedures that will require exposure.</p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>As an eligible Merit employee, you can expect the following:</b></p><p style="text-align:inherit"></p><p style="text-align:left">* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights</p><p style="text-align:left">* Medical/Dental &amp; Other Insurances (eligible the first of month after 30 days)</p><p style="text-align:left">* Low Cost Onsite Medical Clinic</p><p style="text-align:left">* Two (2) Onsite Cafeterias</p><p style="text-align:left">* Employee Garden | Gardening Classes</p><p style="text-align:left">* 3 Weeks&#39; Vacation | 1 Week Sick-Time | Paid Holidays</p><p style="text-align:left">* 401K | Health Savings Account</p><p style="text-align:inherit"></p><p style="text-align:left">To see more on our culture, go to <a href="http://www.merit.com/careers" target="_blank"><span><span><span><span><span class="WOX2">www.merit.com/careers</span></span></span></span></span></a>.</p><p style="text-align:inherit"></p><p style="text-align:left">Military Veterans are encouraged to Apply.</p><p style="text-align:inherit"></p><p style="text-align:left"><b>Merit is a proud Utah Patriot Partner committed to hiring our Veterans.</b></p>