Job Details

ID #23698710
State Texas
City Austin
Job type Contract
Salary USD $30 - $40 per hour 30 - 40 per hour
Source Manpower Engineering
Showed 2021-12-01
Date 2021-12-01
Deadline 2022-01-30
Category Et cetera
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Quality Engineer

Texas, Austin, 78701 Austin USA

Vacancy expired!

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

Vacancy expired!

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