Senior Quality Assurance Engineer - Medical Devices

Marmon Holdings, Inc.; Charlottesville (VA); Hybrid; USD 112,000 - 136,000; Full time

Job summary

Marmon Holdings, Inc. through MicroAire Surgical Instruments LLC is seeking a Principal Quality Assurance Engineer. This senior role leads QA for new medical devices and supports existing products, coordinating CAPA, audits, and supplier quality while mentoring QA staff.

Ideal candidates hold a CQE, an engineering degree, and 8+ years’ medical device QA experience. Travel may be required. Email [e-mail] for details.

Qualifications

• Bachelor's degree in engineering or related field.
• 8+ years in quality assurance for medical devices (mechanical/electrical).
• CQE or equivalent certification required.

Responsibilities

• Leads QA activities for new product development and existing devices.
• Ensures compliance with FDA QSR/ISO 13485 and ISO 14971.
• Manages CAPA, customer complaints, MRB/NCMRs, supplier quality, and risk management.
• Mentors QA Engineers and leads cross-functional quality projects.

Skills

Quality systems

Regulatory compliance

Statistical analysis

Root cause analysis

Cross-functional leadership

Mentoring/Coaching

Technical problem solving

Education

Bachelor's degree in engineering

CQE certification

Tools

DOE

IQ/OQ/PQ

CAPA process

Job description

Marmon Holdings, Inc. through MicroAire Surgical Instruments LLC is seeking a Principal Quality Assurance Engineer. This senior role leads QA for new medical devices and supports existing products, coordinating CAPA, audits, and supplier quality while mentoring QA staff.

Ideal candidates hold a CQE, an engineering degree, and 8+ years’ medical device QA experience. Travel may be required. Email [e-mail] for details.