Quality Engineer, Test Method Validation (TMV)

medmix•Flowery Branch, GA

3d•Onsite

About The Position

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.

Requirements

+4 years of experience in a GMP manufacturing/production environment
+3 years of experience in Metrology including calibration, MSA, TMV and supporting validation activities to ensure accuracy, compliance and data integrity
Bachelor’s degree in Engineering, Quality Management, Manufacturing, or related field.
Knowledge and ability to conduct quality tools and methodologies, including: SPC (Statistical Process Control), FMEA (Failure Mode and Effects Analysis), MSA (Measurement System Analysis), TMV (Test Method Validation), Root Cause Analysis, Lean Manufacturing and Six Sigma principles
Experience with quality management systems and audits.
Strong proficiency with statistical software like Minitab or JMP to analyze data and define acceptance criteria.
Strong analytical and problem-solving skills.
Ability to make decisions regarding product acceptability based on documentation
Demonstrated ability to work with diverse groups and manage conflict
Proficiency in Microsoft Office and quality data analysis tools.
Excellent written and verbal communications skills
Ability to plan, schedule, organize, prioritize, and coordinate project activities
Ability to function in a leadership role and within cross-functional team
Languages: English

Responsibilities

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 equipment
Design, 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 procedures
Serve on internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality-related issues and support continuous improvement
Train personnel in quality and TMV principles
Support Engineering and Metrology in the selection, review, acquisition, and upgrade of systems, production equipment and analysis as required
Share quality philosophies throughout Operations and support Production and Engineering
Perform all company business in accordance with regulations (EEO, FDA, etc.) and company policies
Develop audit responses and complete CAPAs by target due dates; ensure Validation areas are "inspection ready" at all times
Execute actions required to support Change Control, Deviation, and CAPA on-time closure
Ensure 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.