Quality/Validation Engineer - Medical device industry

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 an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Role: Validation Engineer - Medical device industry

Pay Rate: $35/hr on w2

Job Summary:

Quality/Validation Engineer with 5+ years of experience in the medical device industry, specializing in quality, validation, and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root cause investigation, and new product commercialization. Strong analytical, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality, compliance, and continuous improvement initiatives.

• Experience in a GMP and/or ISO regulated medical industry is required.
• Ability to analyze and present data that facilitates & drives decision making is required.
• The ability to perform "hands on" troubleshooting and problem solving is required Experience working in an FDA regulated environment is preferred.
• Experience working in operations supporting a production environment is preferred Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. Measurement System Analysis, SPC, DOEs, Reliability, etc.) is preferred
• Technical understanding of manufacturing equipment and processes is preferred Process Validation expertise is preferred.
• Ability to read and interpret CMM and dimensional inspection reports.
• Experience with dimensional data analysis utilizing software (Excel or Minitab)
• Experience in Medical Standards and Quality process preferred.
• New product launch experience from through full validation and commercial launch
• Experience with PFMEA/DFMEA's, Gage R&R's, TMV's, Risk Assessments and Control Plan
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• Performance Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components.
• Strong communication skills and ability to work well within a multidisciplinary team.
• Proficient with GD&T and interpreting technical drawings.
• Green or Black Belt Six Sigma certification preferred.

Regards,

Sr. Account Manager - Enterprise Business

Net2Source Inc.

[phone]

Office: 270 Davidson Ave, Suite 704, Somerset, NJ 08873

LinkedIn: https://www.linkedin.com/in/prashant-singh-b1b23526