Senior Quality Engineer – Medical Devices & Compliance

Sunrise Systems, Inc.; Covington (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

Sunrise Systems, Inc. is seeking a Quality Engineer for medical device/pharma distribution environments. You will support the quality management system, engage in validation and calibration activities, and ensure compliance with regulatory standards across sites.

The role requires 2–3 years of quality engineering experience, familiarity with ISO 13485 and FDA regulations, and the ability to manage change controls and audits. On-site role based in Covington, GA.

Qualifications

• 2–3 years of quality engineering in medical devices or pharmaceutical distribution/manufacturing.
• ASQ CQA or CQE certification preferred.
• Experience with ISO 13485 and FDA regulations preferred.
• Experience with regulatory submissions and state boards.

Responsibilities

• Support quality management system per GDP, ISO13485 standards.
• Lead validation and calibration for distribution equipment and processes.
• Oversee change control and environmental monitoring at multiple sites.
• Prepare for internal and external audits; address findings.
• Investigate quality deviations and implement corrective actions.
• Ensure documentation control across calibration and risk management.

Skills

Problem solving

ERP systems

FDA/ISO knowledge

Quality engineering

Regulatory submissions

Education

ASQ CQA or CQE

Job description

Sunrise Systems, Inc. is seeking a Quality Engineer for medical device/pharma distribution environments. You will support the quality management system, engage in validation and calibration activities, and ensure compliance with regulatory standards across sites.

The role requires 2–3 years of quality engineering experience, familiarity with ISO 13485 and FDA regulations, and the ability to manage change controls and audits. On-site role based in Covington, GA.