Quality Engineer: Design, Validate & Elevate Product Quality

engineeringjobs.net, Inc.; Bay Shore (NY); On-site; USD 80,000 - 110,000; Full time

Job summary

engineeringjobs.net, Inc. is seeking a Quality Engineer to ensure quality throughout the Product Development Process and lifecycle.

You will contribute to Quality Design and Development, support PDP activities, and drive QA across design, manufacturing, and distribution. The role focuses on risk assessment, design validation, process improvement, regulatory compliance (ISO, FDA), and post-market surveillance collaboration with field teams.

Qualifications

• Experience as a Quality Engineer in manufacturing or product development.
• Strong knowledge of QA methodologies and regulatory requirements.
• Proven ability to drive continuous improvement and CAPA processes.

Responsibilities

• Collaborate on Quality Design & Development activities during PDP.
• Plan and monitor QA measures during new product development.
• Provide ongoing quality support to sustaining manufacturing teams and lead CAPA.
• Ensure quality during product distribution and post-market surveillance.
• Ensure compliance with ISO, FDA, and regulatory standards; prepare documentation.
• Drive continuous improvement using data analysis and metrics.
• Collaborate with engineering, manufacturing, and supply chain to promote quality.

Skills

Quality assurance

Risk management

Root cause analysis

Communication

Problem solving

Regulatory knowledge

Education

Bachelor's degree in engineering, quality management, or a related field

Job description

engineeringjobs.net, Inc. is seeking a Quality Engineer to ensure quality throughout the Product Development Process and lifecycle.

You will contribute to Quality Design and Development, support PDP activities, and drive QA across design, manufacturing, and distribution. The role focuses on risk assessment, design validation, process improvement, regulatory compliance (ISO, FDA), and post-market surveillance collaboration with field teams.