Title:  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