Quality Engineer — Medical Devices

Job overview

The Quality Engineer — Medical Devices role is onsite in Cincinnati, OH. Compensation is not specified. The position focuses on quality, validation, and manufacturing engineering for medical products, including surgical products and implants. The engineer supports compliant and reliable medical product manufacturing by analyzing quality data, investigating issues, validating processes, and qualifying supplier components. The work also contributes to new product launches and continuous improvement in regulated environments.

What you'll do

• Analyze and present data to support decision-making
• troubleshoot and solve production issues
• interpret CMM and dimensional inspection reports and technical drawings
• perform dimensional data analysis using Excel or Minitab
• support process validation, including IQ/OQ/PQ, test method validation, and process characterization
• apply PFMEA/DFMEA, Gage R&R, risk assessments, and control plans
• qualify supplier-manufactured components
• ensure corrective measures meet reliability standards and documentation requirements
• support new product launch through validation and commercial launch.

What we're looking for

Skills & competencies

quality engineer

medical devices

onsite

cincinnati oh

karwell technologies

process validation

iq/oq/pq

pfmea

dfmea

gage r&r

spc

minitab

gmp

iso 13485

fda-regulated

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor's degree in mechanical engineering or equivalent and at least five years of relevant medical product engineering experience; GMP/ISO-regulated medical industry experience required; surgical products and implants experience preferred.

About the employer

Karwell Technologies is hiring for this role. Industry: Engineering Services. Sector: 54.