Senior Quality Engineer, Test Method Validation (TMV)

medmix; Flowery Branch (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

medmix is seeking a Quality Engineer, Test Method Validation (TMV) in the US to ensure reliable, compliant testing across products. Flowery Branch location supports global operations.

You will draft validation plans, conduct MSA and Gauge R&R, and collaborate with R&D, manufacturing and QC teams to drive continuous improvement while upholding FDA and ISO standards. A Bachelor’s degree and 4+ years GMP experience are required.

Qualifications

• Bachelor's degree in Engineering or related field is required.
• +4 years GMP manufacturing/production experience.
• +3 years Metrology including calibration, MSA, TMV and validation support.
• Experience with quality management systems and audits.

Responsibilities

• Draft and execute TMV validation plans, protocols, and test strategies.
• Perform MSA, Gauge R&R, and capability studies to quantify testing variability.
• Develop audit responses and CAPAs with on-time closures.
• Support change controls, deviations, and technology transfer.
• Collaborate with R&D, manufacturing, and quality teams to ensure testability of new designs.
• Train personnel on TMV principles.
• Ensure testing methods meet ISO/FDA requirements and maintain traceability.

Education

Bachelor’s degree in Engineering, Quality Management, Manufacturing, or related field

+4 years GMP manufacturing/production experience

Tools

MSA

TMV

FMEA

SPC

Lean Six Sigma

Quality Management Systems

Minitab/JMP

Job description

medmix is seeking a Quality Engineer, Test Method Validation (TMV) in the US to ensure reliable, compliant testing across products. Flowery Branch location supports global operations.

You will draft validation plans, conduct MSA and Gauge R&R, and collaborate with R&D, manufacturing and QC teams to drive continuous improvement while upholding FDA and ISO standards. A Bachelor’s degree and 4+ years GMP experience are required.