| 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
- 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
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