Specialist I, Quality Operations (Cincinnati, OH, US, 45241)

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,
• 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,
• Engages colleagues with the Enable Values in mind,
• Able 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.

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,
• Aid with Management Review metrics and documentation,
• Provides assistance during Regulatory and customer audits.