Job purpose Secure the success for medmix in the US and global markets by ensuring reliable, cost effective and efficient availability of medmix products and services.  The Test Method Validation (TMV) Quality Engineer is responsible for developing, validating, implementing, and maintaining test methods used to verify product quality and compliance with customer, regulatory, and industry requirements. This role ensures testing processes are accurate, repeatable, reproducible, and statistically sound.Main accountabilities and tasks Contribute to risk assessments (FMEA, etc.) for equipment, processes, and test methods to proactively identify and mitigate compliance and operational risks.Independently draft and execute complex validation plans, protocols, and test strategies (TMV) to ensure compliance and expedited release of critical site equipmentDesign, write, and execute TMV (Test method validation) protocols for new and modified test methods and equipment.Perform measurement system analysis (MSA), Gauge R&R, and capability studies to quantify testing variability and ensure repeatability.Ensure design transfer readiness by standardizing the verification of critical quality attributes, critical process parameters, and control strategies by proper definition, validation, and documentation.Balance competing priorities while ensuring global work is conducted per regulatory requirements and company proceduresServe on internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality-related issues and support continuous improvementTrain personnel in quality and TMV principlesSupport Engineering and Metrology in the selection, review, acquisition, and upgrade of systems, production equipment and analysis as requiredShare quality philosophies throughout Operations and support Production and EngineeringPerform all company business in accordance with regulations (EEO, FDA, etc.) and company policiesDevelop audit responses and complete CAPAs by target due dates; ensure Validation areas are "inspection ready" at all timesExecute actions required to support Change Control, Deviation, and CAPA on-time closureEnsure testing methods meet industry standards (e.g., ISO, FDA), and maintain an airtight evidence trail for regulatory audits.Validate test equipment, fixtures, and software used in the lab to guarantee they produce defect-free, consistent data.Identify root causes of test method failures and modify testing methods or objectives to resolve anomalies.Work alongside R&D, manufacturing, and quality teams to ensure that new product designs are fully testable. 
