Quality Engineer: Design, Risk & Continuous Improvement

Red Seal Recruiting; Bay Shore (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

Red Seal Recruiting is seeking a Quality Engineer to drive quality in the Product Development Process and through the product lifecycle, ensuring regulatory compliance and customer satisfaction.

You will lead QD&D efforts, perform risk assessments, support manufacturing, oversee post-market surveillance, and promote continuous improvement across engineering, manufacturing, and supply chain. A bachelor’s degree and QA experience are required, with Six Sigma or CQE certification a plus.

Qualifications

• Bachelor's degree in engineering or quality management or related field.
• Proven experience as a Quality Engineer in manufacturing or product development.
• Knowledge of QA methodologies, regulatory standards and risk management.
• Experience with CAPA processes and root cause analysis.
• Strong communication and problem-solving skills.
• Certification in quality management (Six Sigma or ASQ CQE) is a plus.

Responsibilities

• Quality Design & Development: collaborate with cross-functional teams on QD&D activities.
• Product Development Process: plan and monitor QA measures, perform risk assessments and validation.
• Sustaining Manufacturing Support: investigate quality issues, lead root cause analysis, implement corrective actions.
• Product Distribution & Post-Market: ensure QA during distribution and support post-market surveillance.
• Compliance & Regulatory: ensure ISO, FDA and applicable regulatory compliance and documentation.
• Continuous Improvement: drive improvements using data analysis and metrics.
• Collaboration & Communication: align with engineering, manufacturing and supply chain to promote quality.

Skills

Quality design

Risk management

Root cause analysis

CAPA

Communication

Problem solving

Regulatory knowledge

Six Sigma

ASQ CQE

Education

Bachelor's degree in engineering or related field

Tools

FMEA

Job description

Red Seal Recruiting is seeking a Quality Engineer to drive quality in the Product Development Process and through the product lifecycle, ensuring regulatory compliance and customer satisfaction.

You will lead QD&D efforts, perform risk assessments, support manufacturing, oversee post-market surveillance, and promote continuous improvement across engineering, manufacturing, and supply chain. A bachelor’s degree and QA experience are required, with Six Sigma or CQE certification a plus.