Quality Engineer, Medical Devices – Validation & GMP Expert

Belcan Corporation; Cincinnati (OH); On-site; USD 69,000 - 83,000; Full time

Job summary

Belcan Corporation is seeking a Quality Engineer for a 24‑month contract in Cincinnati, OH. The role focuses on quality, validation, and manufacturing engineering for surgical products and implants, with strong emphasis on process validation, PFMEA/DFMEA, and GMP/ISO compliance.

Ideal candidates have 6–8 years in medical device quality and hands-on problem solving. Responsibilities include data-driven decision making, working in a cross-functional team, and ensuring documentation meets

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent; minimum 5 years in Quality/Validation/Manufacturing Engineering in medical devices.
• Experience in GMP/ISO regulated environments and surgical products/implants preferred.
• Hands-on problem solving and data-driven decision making are required.

Responsibilities

• Regulatory and quality documentation compliance across projects.
• Analyze data to drive informed decisions and support manufacturing operations.
• Hands-on troubleshooting in production and process validation efforts.
• Lead PFMEA/DFMEA, Gage R&R, and control plans for new components.
• Interpret GD&T and CMM reports; collaborate cross-functionally.

Skills

Quality engineering

Data analysis

Troubleshooting

GD&T

Six Sigma

CMM interpretation

Regulatory compliance

Manufacturing processes

Education

Bachelor's in Mechanical Engineering

5+ years medical device quality experience

Tools

Minitab

Excel

Job description

Belcan Corporation is seeking a Quality Engineer for a 24‑month contract in Cincinnati, OH. The role focuses on quality, validation, and manufacturing engineering for surgical products and implants, with strong emphasis on process validation, PFMEA/DFMEA, and GMP/ISO compliance.

Ideal candidates have 6–8 years in medical device quality and hands-on problem solving. Responsibilities include data-driven decision making, working in a cross-functional team, and ensuring documentation meets