Medical Device Quality Engineer (Associate) – Impactful

HireLifeScience; Johns Creek (GA); On-site; USD 60,000 - 85,000; Full time

Job summary

HireLifeScience seeks an Associate Quality Engineer to maintain quality and control of medical device manufacturing and post-market performance. You will collaborate with internal and external stakeholders, lead root cause investigations, and develop risk-based decisions to resolve issues.

You will ensure compliance with FDA, ISO 13485, and other global regulatory requirements, and represent Quality in cross-functional projects. 0-2 years’ regulated industry experience is expected.

Qualifications

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

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 and implement corrective actions.
• Monitors and analyzes product performance using a statistical and risk-based approach.

Skills

Cross functional communication

Critical thinking

Prioritization

Education

Bachelor's degree in Engineering or Physical Science

ASQ Certification (CQA/CQE/CQM)

Job description

HireLifeScience seeks an Associate Quality Engineer to maintain quality and control of medical device manufacturing and post-market performance. You will collaborate with internal and external stakeholders, lead root cause investigations, and develop risk-based decisions to resolve issues.

You will ensure compliance with FDA, ISO 13485, and other global regulatory requirements, and represent Quality in cross-functional projects. 0-2 years’ regulated industry experience is expected.