Senior Sustaining Quality Engineer – Medical Devices

Apyx Medical; Clearwater (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Apyx Medical is seeking a Senior Sustaining Quality Engineer to ensure compliance of post-market products, manufacturing processes, and the quality programs that support these products. The Senior Sustaining Quality Engineer will support sustainment of manufacturing, product reliability, and process repeatability alongside Operations Engineering.

The role drives continuous improvement of manufacturing processes and Quality Systems to meet regulatory standards.

Qualifications

• Bachelor-level engineering or technical degree required.

Responsibilities

• Support Change Management and ensure timely project deliverables.
• Own the Master Validation Plan and ensure scheduling/validation activities.
• Lead Sterilization Program and periodic bioburden testing.
• Monitor production quality and develop sampling plans.
• Develop test procedures and data-driven quality improvements.
• Promote continuous improvement and CAPA ownership.

Skills

Quality Assurance

Quality Engineering

Manufacturing Engineering

Statistical analysis

CAPA

Root Cause Analysis

Process capability analysis

Minitab

Tableau

FDA/regulatory knowledge

Education

Bachelor's degree in Engineering or technical/scientific field

Tools

Minitab

Tableau

Job description

Apyx Medical is seeking a Senior Sustaining Quality Engineer to ensure compliance of post-market products, manufacturing processes, and the quality programs that support these products. The Senior Sustaining Quality Engineer will support sustainment of manufacturing, product reliability, and process repeatability alongside Operations Engineering.

The role drives continuous improvement of manufacturing processes and Quality Systems to meet regulatory standards.