Senior Quality Engineer, Medical Devices & Validation

TechDigital Group; Cincinnati (OH); On-site; USD 85,000 - 120,000; Full time

Job summary

TechDigital Group is seeking a Quality Engineer with 5+ years' experience in medical devices to lead quality, validation, and manufacturing engineering for surgical products. The role focuses on IQ/OQ/PQ, PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification in GMP, ISO, and FDA environments.

You will read GD&T, analyze dimensional data, investigate root causes, and support new product commercialization.

Qualifications

• Bachelor in Mechanical Engineering or equivalent with 5+ years in Quality/Validation/Manufacturing Engineering in medical products.
• Experience in GMP/ISO/FDA-regulated environments in the medical device industry.
• Strong analytical, problem-solving, and data-driven decision-making skills.
• Experience with PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification.

Responsibilities

• Ensure compliance with GMP and ISO regulated medical industry requirements.
• Analyze data to facilitate decision making and drive improvements.
• Perform hands-on troubleshooting and problem solving in production environments.
• Support new product validation and commercialization.
• Interpret GD&T and dimensional inspection reports.
• Collaborate across multidisciplinary teams.
• Maintain documentation for compliance.
• Lead quality initiatives and continuous improvement.

Skills

Quality engineering

Data analysis

Six Sigma

Cross-functional collaboration

Education

Bachelor in Mechanical Engineering

Tools

Minitab

Excel

CMM

Job description

TechDigital Group is seeking a Quality Engineer with 5+ years' experience in medical devices to lead quality, validation, and manufacturing engineering for surgical products. The role focuses on IQ/OQ/PQ, PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification in GMP, ISO, and FDA environments.

You will read GD&T, analyze dimensional data, investigate root causes, and support new product commercialization.