Senior Quality Engineer: Medical Devices & Compliance

Lancesoft; Covington (GA); On-site; USD 85,000 - 120,000; Full time

Job summary

Lancesoft in Covington, GA seeks a Quality Engineer focused on ensuring GMP/GDP compliance for medical devices and pharmaceuticals. You will support a comprehensive quality management system across calibration, validation, environmental controls, and supplier qualification.

The role requires 2–3 years in quality engineering in distribution/manufacturing, a B.E. in engineering, and familiarity with ISO 13485, FDA regulations, and change control processes.

Qualifications

• Bachelor's degree in engineering required.
• 2-3 years of quality engineering experience in distribution center or medical devices/pharma manufacturing.
• Master's degree preferred; ASQ CQA or CQE certification preferred.
• Experience with ISO 13485 and regulatory submissions is a plus.

Responsibilities

• Quality System Management: support and maintain QMS aligned with GMP/GDP and regulatory standards.
• Quality Operations Oversight: monitor change control, temperature monitoring, validations; drive continuous improvement.
• Validation and Calibration: lead IQ/OQ/PQ protocols; oversee calibration of critical equipment at multiple sites.
• Environmental Monitoring: oversee environmental controls at DCs to protect product integrity.
• Audit and Compliance Readiness: prepare for internal and external audits and address findings.
• Quality Incident Investigation: investigate deviations, implement corrective actions, close investigations.

Skills

Problem solving

ERP systems

FDA/ISO knowledge

Education

Bachelor's degree in engineering

Master's degree in engineering

Job description

Lancesoft in Covington, GA seeks a Quality Engineer focused on ensuring GMP/GDP compliance for medical devices and pharmaceuticals. You will support a comprehensive quality management system across calibration, validation, environmental controls, and supplier qualification.

The role requires 2–3 years in quality engineering in distribution/manufacturing, a B.E. in engineering, and familiarity with ISO 13485, FDA regulations, and change control processes.