Designation: Quality Engineer
Qualification: Bachelor's Degree
- Evaluated and completed non-conformance reports, product complaints, CAPA s and field actions and analyzed if they should be escalated to a CAPA.
- Direct all phases of CAPA from initiation to closure.
- Ensures overall execution of the CAPA in a timely manner, follows the CAPA Process, and documents and communicates results which includes coordinating and assigning CAPA failure investigation activities, Ensure CAPA reflects up-to-date information.
- Assist with the investigation of Corrective and Preventive Actions (CAPA) to determinate the root causes (s) using fishbone diagram, 5 Whys, etc.
- Evaluate and complete non-conformance reports, product complaints, CAPA s and field actions and analyzed if they should be escalated to a CAPA.
- Schedule CAPA team meetings and ensured CAPA deliverables per project timelines.
- Perform and documented timely Corrective and Preventive Actions (CAPA) investigations.
- Document associated with all phases of CAPA in compliance to 21CFR part 820.100 and ISO 13485.
- Driving timely execution of NCRa deliverables through monitoring and reporting status to NCR owners.
- Implementing current good manufacturing practices and providing training to assigned trainees about cGMP.
- Overseeing the CAPA activities to ensure the actions are completed appropriately and with appropriate objective evidence.
- Optimization of new and existing processes used for manufacturing medical device to meet specific clinical goals.
- Executing Gap and impact as part of procedures integration.
Bachelors Degree: Industrial Engineering or related field of study.