Senior Quality Engineer, Medical Devices & Validation

Belcan; Cincinnati (OH); On-site; USD 95,000 - 120,000; Full time

Job summary

Belcan is seeking a Quality Engineer with 6 to 8 years of experience in the medical device industry to lead quality, validation, and manufacturing engineering for surgical products and implants.

The role requires performing IQ/OQ/PQ, PFMEA/DFMEA, Gage R&R, SPC, and DOE, plus risk assessments and supplier qualification within GMP, ISO, and FDA-regulated environments. Strong analytical and cross-functional collaboration skills are essential to drive continuous improvement.

Qualifications

• Bachelor in Mechanical Engineering with at least 5 years in Quality/Validation/Manufacturing in medical products.
• Experience with surgical devices and implants preferred.
• Experience in GMP/ISO regulated environments and FDA-regulated environments preferred.

Skills

Quality engineering

Validation

Manufacturing engineering

GMP/ISO/FDA

PFMEA/DFMEA

Gage R&R

SPC/DOE

Risk assessments

Supplier qualification

GD&T interpretation

Dimensional analysis

Root cause analysis

New product introductions

Six Sigma (Green/Black Belt)

Education

Bachelor's degree in Mechanical Engineering

Tools

Excel

Minitab

Job description

Belcan is seeking a Quality Engineer with 6 to 8 years of experience in the medical device industry to lead quality, validation, and manufacturing engineering for surgical products and implants.

The role requires performing IQ/OQ/PQ, PFMEA/DFMEA, Gage R&R, SPC, and DOE, plus risk assessments and supplier qualification within GMP, ISO, and FDA-regulated environments. Strong analytical and cross-functional collaboration skills are essential to drive continuous improvement.