Abbott is seeking a Quality Assurance Specialist to help manage the audit process and ensure compliance with local, divisional, and corporate procedures, as well as conforming to the Quality Systems Regulations (21CFR 820), ISO 13485:2003, and other applicable regulations and standards
Requirements
- Bachelors degree in scientific, technical, or compliance discipline
- 2 -3 years experience in the industry
- 2-3 years experience in a quality assurance function
- Prior experience with quality compliance audits
- Prior experience collaborating cross functionally
Responsibilities
- Plans, prepares and executes internal and external audits
- Supports record archival activities, including coordinating record retrieval from archives
- Prepares updates and maintains documentation for internal and external audits
- Assists management in development of an effective system for integrating information from internal audits
- Provides reports in a timely manner
- Includes the review of recent audit activity, analysis of data, preparation and follow up on action items
- Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
Other
- Bachelors degree in scientific, technical, or compliance discipline
- 2 -3 years experience in the industry
- Travel: Yes, 5 % of the Time
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
- Keyboard use (greater or equal to 50% of the workday)
