Date: Jul 25, 2025 Employment Schedule: Location: Stokesdale, NC, US, 27320 Validation Quality Engineer

We’re looking for a Validation Quality Engineer to bring P.R.I.D.E. to our Quality team. ​ Why does this job exist at Ontex? To execute the core activities for each Quality stream and ensure these activities are in compliance with the QMS.

Bridge the gap between the project launch and manufacturing on all new assets and raw material for validations and data analysis (monitoring the process, collecting samples, coordinating lab activities)

Primary point of contact for all sample request execution.

Assist with investigations from customer feedback and/or complaints. (Testing, data analysis, trial completion, investigation scope)

Validate CAPA/RCPS

Coordinate with supply chain and lab for new raw material inspections.

Organize, enter and analyze data in a manner that allows educated decisions to be made by leadership.

Monitor production data CPK’s for trends and initiate improvement activities based on this data. Other duties as required. How big is the job? By ensuring compliance of the described procedures per area the lean manufacturing approach is also covered therefore the speed in the supply chain is directly linked to this execution role.

The data analysis from each person with this role allows to take decision and reduce the losses in the entire supply chain.

Successful validations are critical to ensure we have vertical startup on all new asset and raw material launches. What am I expected to deliver, and what are my main tasks? Organize and execute what the procedures of the assigned areas describe.

Propose improvement based on a data driven mindset. Communicate with the manufacturing, supply chain, industrialization and R&D with any opportunity or deviation to procedures.

Support the root cause analysis for any loss identified in the assigned area.

Become owner of KPI’s in assigned area.

Ensure that every loss is assessed through a PDCA approach. With whom do I need to collaborate to get the job done? Technical, production, supply chain departments in the plant are needed to ensure the lean approach is followed through the entire supply chain. How complex is the stuff I’m dealing with, and how do I solve problems? How complex is the stuff I’m dealing with? The main complexity in this role is to work independently and to prioritize tasks based on business needs. Identifying issues, driving them to closure and reporting results to leadership will be a common task. How do I deal with problems as they arise? As a team with RCPS approach. What do I need to be successful in this job? What is the educational requirement for the job? Bachelor in Technical or Engineering degree. 5 years of experience in a quality or manufacturing environment is also an acceptable substitute. What prior experience is required for the job? 5 years of experience in a quality or manufacturing environment. Which technical skills do I need to master? Detailed knowledge of product and production processes in the plant.

Basic knowledge of quality management systems.

English written and verbal intermediate, any other language is considered as an asset.

Intermediate knowledge of IT systems (ERP’s, Office or G suites)

Proficiency with lab equipment and reporting

Basic understanding of blueprints and specifications What are the core competencies for the job? Be able to work with cross functional teams and communicate with team outside of the plant environment.

Analytical skills and communication skills.

Problem solving and root cause analysis. Here for you.

Nearest Major Market: Greensboro