Abbott is seeking a Product Quality Assurance Associate Analyst I to support the efficient functioning of Quality Assurance and the Quality System at Abbott Diabetes Care in Alameda, CA
Requirements
- Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices
- Knowledge of ISO 13485 standard
- Knowledge of quality management techniques and application
- Ability or aptitude to use various types of databases and other computer software
- Medical device industry experience preferred
- Knowledge of quality audits, validation and equipment maintenance
- Ability to quickly gain knowledge, understanding or skills and is willing to learn
Responsibilities
- Responsible for implementing and maintaining the effectiveness of the Quality System
- Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation
- Assist in determining quality attributes and requirements
- Utilize quality management techniques to perform investigations and facilitate solutions
- Responsible for completing documentation in a timely manner and in accordance with business standards
- Participate on cross-functional teams
- Understand and comply with applicable EHS policies, procedures and guidelines
Other
- Bachelor’s degree required
- Masters Degree preferred
- 0-3 years of experience in a combination of internship, co-op or equivalent experience
- Ability to clearly, concisely and accurately convey communications
- Ability to form and develop interpersonal, professional relationships
- Ability to work independently and in groups
