Abbott is seeking a Quality Assurance Engineer III to serve as the primary QA representative on new product design and on-market development/change teams, ensuring compliance with design control requirements and regulations in the medical device industry.
Requirements
- Bachelors Degree in Engineering, Life Sciences or Physical Sciences.
- Minimum 5 yrs experience in Quality Assurance, Technical Quality.
- Minimum 3 years experience in the medical device industry.
- Some knowledge in the areas of design controls, V&V activities, mfg practices/proceses and statistical techniques.
- Some applicable experience with regulations and standards such as FDA, QSR and ISO regulations.
- AA Degree plus 8+ yrs of experience will be considered.
- Experience with design control systems and quality management systems.
Responsibilities
- Monitor and report to upper management on design control related projects.
- Participate in continuous improvement initiatives as appropriate for the design control system.
- Assist in the development, approval, and change control of design history documentation.
- Monitor and maintain DHF requirements in accordance with project timeline and design control requirements.
- Actively engage with Operations and Engineering to implement design control deliverables.
- Collect and analyze quality information/data from various quality systems and develop reports.
- Conduct or assist in systems/process/product failure mode and effects analysis and initiation of corrective and/or preventative action.
Other
- Bachelors Degree in Engineering, Life Sciences or Physical Sciences.
- Travel: Yes, 10 % of the Time
- Work Shift: Standard
- Medical Surveillance: No
- Significant Work Activities: Continuous sitting for prolonged periods, Keyboard use
- Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
