Senior Quality Assurance Engineer – Medical Devices Leader

MicroAire Surgical Instruments; Charlottesville (VA); On-site; USD 112,000 - 136,000; Full time

Job summary

MicroAire Surgical Instruments LLC is seeking a Principal Quality Assurance Engineer to lead QA for medical devices, including CAPAs, complaints, supplier quality, and validations. You will mentor QA Engineers and drive risk management, design controls, and regulatory compliance.

Requires 8+ years in QA/manufacturing for medical devices, CQE or equivalent, and strong problem-solving with ISO/FDA guidelines. Office-based in Charlottesville with occasional travel.

Qualifications

• Bachelor's degree in engineering or related field; CQE or equivalent required.
• Minimum 8 years of QA/manufacturing experience in the medical device industry.
• Experience with FDA QSR/21 CFR 820, ISO 13485, ISO 14971 is required.
• Lean-Six-Sigma experience preferred.

Responsibilities

• Lead quality activities for new product development and existing devices.
• Manage CAPAs, customer complaints, MRB/NCMRs, supplier quality, and audits.
• Develop validation plans and risk analyses; ensure design controls compliance.
• Mentor QA Engineers and collaborate with cross-functional teams.

Skills

Quality assurance

CAPA management

Regulatory compliance

Risk analysis

Design of Experiments

Statistical analysis

Root cause analysis

Internal auditing

Leadership

Education

Bachelor's degree in engineering

Job description

MicroAire Surgical Instruments LLC is seeking a Principal Quality Assurance Engineer to lead QA for medical devices, including CAPAs, complaints, supplier quality, and validations. You will mentor QA Engineers and drive risk management, design controls, and regulatory compliance.

Requires 8+ years in QA/manufacturing for medical devices, CQE or equivalent, and strong problem-solving with ISO/FDA guidelines. Office-based in Charlottesville with occasional travel.