Senior Quality & Validation Engineer - Medical Devices

Net2Source (N2S); Cincinnati (OH); On-site; USD 41,000 - 55,000; Full time

Job summary

Net2Source Inc. is seeking a Validation Engineer for the medical device industry with 5+ years of experience in quality, validation, and manufacturing engineering for surgical products and implants.

Responsibilities include IQ/OQ/PQ, PFMEA/DFMEA, Gage R&R, SPC, DOE, and supplier qualification in GMP/ISO/FDA environments. Strong analytical and cross-functional collaboration skills are required.

Qualifications

• Experience in GMP and/or ISO regulated medical environments is required.
• Ability to analyze data to facilitate decision making is required.
• Hands-on troubleshooting and problem solving in a production setting preferred.
• Experience in FDA-regulated environments is preferred.
• Six Sigma knowledge (Lean/Six Sigma) preferred.

Responsibilities

• Quality/validation engineer focused on medical device products and implants.
• Perform IQ/OQ/PQ, PFMEA/DFMEA, and validation activities for manufacturing processes.
• Analyze dimensional data and use GD&T to support product qualification.
• Drive continuous improvement and ensure regulatory compliance across programs.
• Collaborate with cross-functional teams to support new product launches.

Skills

GMP/ISO knowledge

FDA-regulated experience

Process validation

PFMEA/DFMEA

Gage R&R

SPC/DOE

Quality engineering

GD&T interpretation

Data analysis

Root cause analysis

Tools

Minitab

Excel

Job description

Net2Source Inc. is seeking a Validation Engineer for the medical device industry with 5+ years of experience in quality, validation, and manufacturing engineering for surgical products and implants.

Responsibilities include IQ/OQ/PQ, PFMEA/DFMEA, Gage R&R, SPC, DOE, and supplier qualification in GMP/ISO/FDA environments. Strong analytical and cross-functional collaboration skills are required.