About this role
<p> </p> <table style="border-collapse:collapse;width:69%;border-style:none" border="0"><colgroup><col style="width:26%"><col style="width:74%"></colgroup> <tbody> <tr> <td> </td> <td> <p><strong>Location:</strong> Onsite</p> <p><strong>Status Type:</strong> Full Time</p> <p> </p> <p><strong>QUALIFICATIONS</strong></p> <p> </p> <p><strong><span style="text-decoration:underline">Required:</span></strong></p> <p>Bachelor’s Degree or equivalent combination of education, training, and experience.</p> <p> </p> <p><strong><span style="text-decoration:underline">Preferred:</span></strong></p> <ul> <li>Audit report writing skills</li> <li>Strong communication skills – verbal and written</li> <li>Strong problem-solving skills</li> <li>Strong interpersonal skills</li> <li>Understanding of product complaint requirements</li> <li>Some understanding of device and/or pharmaceutical regulatory and compliance requirements</li> </ul> <p> </p> <p><span style="text-decoration:underline"><strong>Skills & Competencies:</strong></span></p> <ul> <li>Strong computer skills including Microsoft Office and databases/excel spreadsheets</li> <li>Knowledge of e-mail/scheduling software application</li> <li>Ability to learn and utilize future software/applications as it is deployed</li> <li>Ability to adapt to change and handle unexpected situations with close guidance.</li> <li>Accepts direction on how to adapt approach to changing situations.</li> <li>Ability to follow defined procedures</li> <li>Ability to stay focused on tasks, organize, compare, interpret basic data, and assess problems with guidance.</li> <li>Work to acquire and develop new skills</li> <li>Ability to collaborate and maintain cooperative work relationships with others.</li> <li>Engages colleagues with the Enable Values in mind</li> <li>Ability to maintain a positive attitude, show empathy for others, and always do the right thing</li> <li>Good time management skills</li> </ul> <p> </p> <p><strong><span style="text-decoration:underline">Physical Requirements:</span></strong></p> <ul> <li>Must be able to remain in a stationary position for extended periods of time</li> <li>Ability to lift and lower boxes of documents or handle equipment weighing up to 25 lbs.</li> <li>Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.</li> <li>Position requires being physically present on the premises during regular company hours or as approved by</li> <li>management.</li> </ul> <p> </p> <p><strong><span style="text-decoration:underline">RESPONSIBILITIES:</span></strong></p> <ul> <li>Assist with Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies</li> <li>Assists with the assembly and execution of Management Reviews</li> <li>Support Corrective and Preventive (CAPA) and Nonconformance programs</li> <li>Assists Quality Management in providing guidance on compliance related issues</li> <li>Ensures product safety, regulatory compliance, and compliance through proper management of quality documents and quality records</li> <li>Updates quality procedures and work instructions, when required</li> <li>Identifies areas of opportunity to reduce waste and improve efficiency</li> <li>Assist with Management Review metrics and documentation</li> <li>Provides assistance during Regulatory and customer audits</li> </ul> </td> </tr> </tbody> </table> <p> </p>