Associate Quality Engineer - Medical Devices (Onsite)

HonorVet Technologies; Johns Creek (GA); On-site; USD 45,000 - 65,000; Full time

Job summary

HonorVet Technologies in Johns Creek, GA is seeking an Associate Quality Engineer for a 24-month onsite night-shift role. You will maintain quality and control of manufacturing processes and oversee post-market performance of medical devices, collaborating across teams on root-cause investigations and risk-based decisions.

You will lead issue investigations, document actions, and support cross-functional projects, ensuring FDA and ISO 13485 compliance in a fast-paced environment.

Qualifications

• 0-2 years of experience in Medical Device/Pharmaceutical regulated industry.
• Minimal - Bachelor's Degree with Engineering or Physical Science coursework.
• Preferred - Bachelor's or Master's Degree in Engineering with 0-3 years' experience in Medical Device/Pharmaceutical regulated industry; ASQ Certification (e.g. CQA, CQE, CQM).

Responsibilities

• Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
• Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness.
• Monitors and analyses product performance of medical devices using a statistical and risk-based approach; considers quality, compliance, customer, and business risks.
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation.
• Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization.
• Proficient in project management, data analysis, root cause analysis, communication, and risk determination.
• Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.

Skills

Cross functional communication

Critical thinking

Prioritization

Education

Bachelor's Degree in Engineering or Physical Science

Bachelor's or Master's Degree in Engineering + ASQ Certification (preferred)

Job description

HonorVet Technologies in Johns Creek, GA is seeking an Associate Quality Engineer for a 24-month onsite night-shift role. You will maintain quality and control of manufacturing processes and oversee post-market performance of medical devices, collaborating across teams on root-cause investigations and risk-based decisions.

You will lead issue investigations, document actions, and support cross-functional projects, ensuring FDA and ISO 13485 compliance in a fast-paced environment.