Senior Quality Engineer - Medical Devices & QMS Leader

Marmon Holdings, Inc.; Charlottesville (VA); On-site; USD 87,000 - 105,000; Full time

Job summary

MicroAire Surgical Instruments LLC, part of Marmon Holdings (backed by Berkshire Hathaway), is hiring a Senior Quality Engineer to lead the quality system for new and existing medical devices.

You will partner with R&D, Manufacturing and suppliers to strengthen QMS, pursue CAPA and risk management, and support design verification/validation, IQ/OQ/PQ, packaging validation and process qualification to speed time-to-market while ensuring compliance.

Qualifications

• Bachelor's degree in engineering or science.
• Six years of Quality or Manufacturing Engineering experience.
• Medical device experience highly desirable; regulated industry experience required.
• Lean-Six-Sigma experience preferred; CQE preferred.

Responsibilities

• Lead and participate in quality system activities for medical devices.
• Develop quality plans and support CAPA and risk management.
• Support IQ/OQ/PQ, design verification/validation, and supplier quality.
• Perform quality audits and drive continuous improvement across functions.

Skills

QMS knowledge

Risk analysis

Design validation

Cross-functional leadership

Continuous improvement

Education

Bachelor's degree in engineering or science

Tools

IQ/OQ/PQ

FMEA

CAPA systems

QMS software

Job description

MicroAire Surgical Instruments LLC, part of Marmon Holdings (backed by Berkshire Hathaway), is hiring a Senior Quality Engineer to lead the quality system for new and existing medical devices.

You will partner with R&D, Manufacturing and suppliers to strengthen QMS, pursue CAPA and risk management, and support design verification/validation, IQ/OQ/PQ, packaging validation and process qualification to speed time-to-market while ensuring compliance.