Quality Engineer: Medical Devices/Pharma ISO13485 & Validation

Kaygen, Inc.; Covington (GA); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Free Healthcare Insurance

401(k) Retirement Plan

Free Life Insurance

Sick Time Off

Certifications

Referrals

Family and Wellness benefits

Continuous Growth and Career Deve­lopm

Job summary

Kaygen, Inc. is seeking a Quality Engineer III to support a distribution of medical devices and pharmaceuticals in Covington, GA.

The role focuses on maintaining the quality management system, ensuring compliance with GMP/GDP standards, and leading or supporting supplier qualifications, calibration, and validation efforts. The ideal candidate has 2–3 years in quality engineering in medical devices/pharma, knowledge of ISO 13485 and FDA regulations, and experience with ERP systems.

Qualifications

• 2–3 years of experience in quality engineering within distribution or manufacturing of medical devices or pharmaceuticals.
• Strong problem-solving and analytical skills.
• Experience with ERP systems and regulatory standards (FDA/ISO 13485).

Responsibilities

• Provide engineering support to maintain a quality management system aligned with medical device/pharma distribution.
• Lead validation, calibration, IQ/OQ/PQ protocol activities for equipment and processes.
• Support audits and compliance readiness, investigations, corrective actions, and change control.

Skills

Quality engineering

Problem solving

ERP systems

FDA regulations

ISO 13485

Education

ASQ CQA or CQE certification

Job description

Kaygen, Inc. is seeking a Quality Engineer III to support a distribution of medical devices and pharmaceuticals in Covington, GA.

The role focuses on maintaining the quality management system, ensuring compliance with GMP/GDP standards, and leading or supporting supplier qualifications, calibration, and validation efforts. The ideal candidate has 2–3 years in quality engineering in medical devices/pharma, knowledge of ISO 13485 and FDA regulations, and experience with ERP systems.