Quality Engineer: Design & Regulatory Excellence

Top Echelon LLC; Bay Shore (NY); On-site; USD 70,000 - 110,000; Full time

Job summary

Top Echelon LLC is seeking a Quality Engineer to ensure quality throughout the Product Development Process and lifecycle. You will support Quality Design & Development during design, and sustain manufacturing with root-cause analysis and CAPA implementation.

Responsibilities include risk assessments, design validation, regulatory compliance (ISO, FDA), post-market support, and data-driven continuous improvement. Strong collaboration with engineering and manufacturing is essential.

Qualifications

• Bachelor’s degree or higher in engineering, quality management, or related field.
• Proven experience in quality engineering within manufacturing or product development.
• Strong knowledge of QA methodologies and regulatory requirements.
• Experience with risk management, RCA, CAPA processes.
• Excellent communication and problem-solving skills.
• Certification in quality management (Six Sigma, ASQ CQE) is a plus.

Responsibilities

• Quality Design & Development: support QD&D during PDP and ensure quality requirements are defined and followed.
• PDP: plan and monitor QA measures, conduct risk assessments, design validation and verification.
• Sustaining Manufacturing Support: lead investigations and corrective actions for manufacturing quality issues.
• Product Distribution & Post-Market Support: monitor quality during distribution and assist field teams.
• Compliance & Regulatory: ensure ISO/FDA compliance and prepare documentation for audits.
• Continuous Improvement: drive data-driven improvements in quality processes and systems.
• Collaboration & Communication: work with engineering, manufacturing and supply chain teams.

Skills

Quality assurance methodologies

Regulatory requirements

Risk management

Root cause analysis

Corrective actions

Preventive actions

Communication

Problem-solving

Education

Bachelor’s degree in engineering, quality management, or related field

Job description

Top Echelon LLC is seeking a Quality Engineer to ensure quality throughout the Product Development Process and lifecycle. You will support Quality Design & Development during design, and sustain manufacturing with root-cause analysis and CAPA implementation.

Responsibilities include risk assessments, design validation, regulatory compliance (ISO, FDA), post-market support, and data-driven continuous improvement. Strong collaboration with engineering and manufacturing is essential.