Quality Systems Engineer - Medical Devices & Pharma

Planet Pharma; Covington (GA); On-site; USD 55,000 - 62,000; Full time

Job summary

Planet Pharma is seeking a Quality Engineer to oversee the quality system for the distribution of medical devices and pharmaceuticals at multiple sites in Covington, GA.

You will ensure compliance with FDA regulations and ISO 13485, lead validations and calibrations, monitor environmental conditions, and support audits and investigations to drive continuous improvement.

This role requires a engineering degree and 2–3 years in quality engineering within a distribution or manufacturing environment.

Qualifications

• Bachelor’s degree in engineering.
• 2–3 years of experience in quality engineering within a distribution center or manufacturing of medical devices or pharmaceuticals.
• Experience with ISO 13485, certification preferred.
• ASQ CQA or CQE certification is a plus.

Responsibilities

• Quality System Management: maintain a comprehensive quality management system aligned with regulatory standards.
• Quality Operations Oversight: monitor change control, temperature monitoring and validations with continuous improvement strategies.
• Validation and Calibration Expertise: lead IQ/OQ/PQ protocol writing, execution and approvals; oversee calibration of critical instrumentation.
• Environmental Monitoring: monitor distribution center conditions and shipping controls to protect product integrity.
• Audit and Compliance Readiness: prepare for internal and external audits and address outcomes.
• Quality Incident Investigation: drive investigations and implement corrective actions to prevent recurrence.
• Document and Change Management: maintain controlled procedures and manage change control across sites.

Skills

Quality engineering

Regulatory knowledge

Problem-solving

ERP systems experience

FDA/ISO knowledge

Education

Bachelor’s degree in engineering

Master’s degree in engineering

ASQ CQA or CQE certification

Tools

ERP systems

Regulatory submission tools

Job description

Planet Pharma is seeking a Quality Engineer to oversee the quality system for the distribution of medical devices and pharmaceuticals at multiple sites in Covington, GA.

You will ensure compliance with FDA regulations and ISO 13485, lead validations and calibrations, monitor environmental conditions, and support audits and investigations to drive continuous improvement.

This role requires a engineering degree and 2–3 years in quality engineering within a distribution or manufacturing environment.