Validation Engineer (Medical Device Industry)

Job Description

Job Description

Writing

Job Title: Validation Engineer (Medical Device)

Location: Marietta, GA (Open to Local Candidates within Georgia)

Positions Available: 3

Employment Type: Contract through ProQuality Network

Summary

ProQuality Network is seeking highly skilled Validation Engineers to support our Medical Device client in Marietta, Georgia. This opportunity is open exclusively to local candidates within the state of Georgia and is offered on a contract basis. Selected professionals will play a key role in ensuring compliance with FDA, ISO, and international medical device regulations by executing robust validation protocols, qualifying equipment and systems, and collaborating cross-functionally to drive quality and operational excellence.

Key Responsibilities

• Develop, execute, and maintain validation deliverables including Validation Master Plans (VMP), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support validation of molding equipment, automated/manual assembly processes, robotics, conveyors, bowl feed systems, and servo/PLC-controlled systems.
• Assess fixture/tooling qualifications, ergonomic considerations, and environmental controls.
• Conduct validation and qualification activities for MES/SCADA systems in FDA-regulated environments.
• Perform testing such as torque, vision system evaluation, and functional performance validation.
• Interpret and apply applicable regulations and standards, including 21 CFR Part 820 (FDA QSR), EU MDR 2017/745, ISO 9001, and ISO 13485.
• Document all validation activities with strong technical writing and reporting standards.
• Provide training to personnel on validation protocols, equipment usage, and compliance practices.
• Collaborate with design, manufacturing, and quality teams to ensure alignment across functions.
• Apply root cause analysis and problem-solving methodologies to address deviations and process gaps.

Required Qualifications

• Bachelor’s degree (or higher) in Engineering (Mechanical, Biomedical, Chemical, Industrial, or related).
• Strong experience with IQ/OQ/PQ protocols and equipment calibration procedures.
• Knowledge of automated and manual assembly techniques, including robotics and process control systems.
• Hands-on experience in medical device validation within a GMP/FDA-regulated environment.
• Proficiency in technical documentation, reporting, and regulatory compliance.
• Strong analytical mindset with proven problem-solving skills.

Preferred Qualifications

• Certifications in ISO 14971 Risk Management and ISO 13485 Quality Management Systems.
• Six Sigma/Lean Manufacturing credentials (Green Belt or Black Belt).
• GMP training and proven understanding of international quality standards.
• Experience with KNEAT software (highly desirable).

Application Note: This opportunity is exclusively open to local candidates in Georgia. Interested candidates are invited to apply through the job description link with an updated resume.