Specialist I, Quality Operations

Location: Onsite Status Type: Full Time QUALIFICATIONS Required: Bachelor’s Degree or equivalent combination of education, training, and experience. Preferred: Audit report writing skills Strong communication skills – verbal and written Strong problem-solving skills Strong interpersonal skills Understanding of product complaint requirements Some understanding of device and/or pharmaceutical regulatory and compliance requirements Skills & Competencies: Strong computer skills including Microsoft Office and databases/excel spreadsheets Knowledge of e-mail/scheduling software application Ability to learn and utilize future software/applications as it is deployed Ability 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 procedures Ability to stay focused on tasks, organize, compare, interpret basic data, and assess problems with guidance. Work to acquire and develop new skills Ability to collaborate and maintain cooperative work relationships with others. Engages colleagues with the Enable Values in mind Ability to maintain a positive attitude, show empathy for others, and always do the right thing Good time management skills Physical Requirements: Must be able to remain in a stationary position for extended periods of time Ability 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. RESPONSIBILITIES: Assist with Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies Assists with the assembly and execution of Management Reviews Support Corrective and Preventive (CAPA) and Nonconformance programs Assists Quality Management in providing guidance on compliance related issues Ensures product safety, regulatory compliance, and compliance through proper management of quality documents and quality records Updates quality procedures and work instructions, when required Identifies areas of opportunity to reduce waste and improve efficiency Assist with Management Review metrics and documentation Provides assistance during Regulatory and customer audits