PDS Tech Inc Engineer I, QA/QC in Austin, Texas
PDS Tech is seeking candidates for an Engineer I QA/QC
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
How will you get here?
Bachelor’s degree in life sciences, engineering, process engineering, chemistry, biotechnology or related sciences
Experienced working in ISO 9001, 13485, USDS and/or GMP environment
1-3 years of work experience in Quality Assurance/Quality Systems role. Laboratory experience and/or experience with PCR-based technologies a plus (e.g. manufacturing, QC or R&D).
Strong computer skills (Office, Project, Teams, Visio, Word, Excel) and experience in E1, SAP, Agile, TrackWise, and Power BI. Advanced computer skills preferred.
Experienced with Quality tools, methodologies, and complaint investigations, including root cause analysis
Experienced working & collaborating effectively with internal and external customers
Experienced in improving site’s Quality Management System and promoting site Quality
Experienced working & collaborating with internal and external customers
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.