Quality Engineer



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Branch Information

Atlanta Engineering - (USA) 7000 Central Park Northeast Suite 950 GA Atlanta , GA 30328



Job Description

As a QA Engineer, you will help to ensure the Austin site meets all the requirements for ISO-9001, ISO-13485, 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA), Quality Systems Regulation (QSR) and USDA regulations.

You will partner with various Operations teams to support the on-time delivery of quality product through the following activities:

* Perform Batch Record Review and help with Product Release

* Archival of manufacturing and QC records

* Sample Retain management

* Recommend improvements to processes and procedures; may help revise procedures.

* Perform other duties to support the Quality department as assigned.

* Duties will include complaint handling, will work with the cross-functional department on complaint cases for investigations, root cause analysis, and corrections/corrective actions to ensure proper documentation and closure, provide trending and escalations as appropriate

* Participate in internal audits per ISO 13485 and 9001 requirements and ensure site audit readiness

* Support internal Quality activities concerning any identified nonconformities

* Participate in departmental projects and improvement initiatives through the site's PPI Program and partner with other groups to continuously improve

* Prepare clearly written business communications, including audit reports, gap assessments, validations, etc.

* Generate and fulfill customer request for COAs, COCs, COOs

* Perform other duties to support the quality and regulatory department as assigned.

* Creating problem reports for nonconforming raw material

* Ensuring discrepancies are thoroughly identified, defined, and properly assessed.

* Interacting with interdepartmental contacts on change and discrepancy assessment, resolution, and quality approval.

* Providing timely information to Operation.

* Update and meet metrics

* Identifying opportunities for continuous improvement of the Quality Systems and participate in implementation.

* Maintain calibrated tools and equipment

* Be able to communicate technical issues and inspection results orally and in writing.

* Ability to work independently and as part of the QA Team

* Sense of urgency with completion of projects and tasks

* Serves as a backup for other Quality positions as needed