Specialist I, Quality Operations

Title: Specialist I, Quality OperationsDescriptionLocation: OnsiteStatus Type: Full TimeQualificationsRequired: Bachelor’s Degree or equivalent combination of education, training, and experience. PreferredAudit report writing skillsStrong communication skillsStrong problem-solving skillsStrong interpersonal skillsUnderstanding of product complaint requirementsSome understanding of device and/or pharmaceutical regulatory and compliance requirementsSkills & CompetenciesStrong computer skills including Microsoft Office and databases/excel spreadsheetsKnowledge of e-mail/scheduling software applicationAbility to learn and utilize future software/applications as it is deployedAbility to adapt to change and handle unexpected situations with close guidance.Accepts direction on how to adapt approach to changing situations.Ability to follow defined proceduresAbility to stay focused on tasks, organize, compare, interpret basic data, and assess problems with guidance.Work to acquire and develop new skillsAbility to collaborate and maintain cooperative work relationships with others.Engages colleagues with the Enable Values in mindAbility to maintain a positive attitude, show empathy for others, and always do the right thingGood time management skillsPhysical RequirementsMust be able to remain in a stationary position for extended periods of timeAbility to lift and lower boxes of documents or handle equipment weighing up to 25 lbs.Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.Position requires being physically present on the premises during regular company hours or as approved by management.ResponsibilitiesAssist with Batch Disposition responsibilities for Materials, Components, and Sub-AssembliesAssists with the assembly and execution of Management ReviewsSupport Corrective and Preventive (CAPA) and Nonconformance programsAssists Quality Management in providing guidance on compliance related issuesEnsures product safety, regulatory compliance, and compliance through proper management of quality documents and quality recordsUpdates quality procedures and work instructions, when requiredIdentifies areas of opportunity to reduce waste and improve efficiencyAssist with Management Review metrics and documentationProvides assistance during Regulatory and customer auditsNearest Major Market: Cincinnati