Quality Engineer: Design, Validation & CI

H. T. PROF Group; Bay Shore (NY); On-site; USD 85,000 - 115,000; Full time

Job summary

H. T. PROF Group is seeking a Quality Engineer to ensure quality across the Product Development Process and lifecycle. You will support QD&D during design, participate in PDP QA activities, and drive improvements in manufacturing and post-market quality.

The role requires a strong background in quality assurance, risk management, and regulatory compliance, with excellent communication to collaborate across engineering, manufacturing, and supply chain.

Qualifications

• Bachelor's degree in engineering, quality management, or a related field.
• Proven experience as a Quality Engineer in manufacturing or product development.
• Strong knowledge of quality assurance methodologies and regulatory requirements.
• Proficient in risk management, root cause analysis, and CAPA.
• Excellent communication and problem-solving skills.
• Certification in quality management systems (e.g., Six Sigma, ASQ CQE) is a plus.

Responsibilities

• Collaborate with cross-functional teams to support Quality Design & Development (QD&D) activities throughout the PDP.
• Participate in planning, execution, and monitoring of QA measures in new product development; conduct risk assessments, validation, and verification.
• Provide ongoing quality support to sustaining manufacturing; lead root cause analysis and implement corrective actions.
• Ensure quality during product distribution and support post-market surveillance activities.
• Maintain compliance with ISO, FDA, and other regulatory standards; prepare documentation for audits.
• Drive continuous improvement using data analysis to identify and implement quality enhancements.
• Work with engineering, manufacturing, and supply chain to promote a culture of quality and clear communication.

Skills

Quality assurance

Root cause analysis

Risk management

Regulatory compliance

CAPA

Communication

Documentation

Six Sigma

Education

Bachelor's degree in engineering or related field

Job description

H. T. PROF Group is seeking a Quality Engineer to ensure quality across the Product Development Process and lifecycle. You will support QD&D during design, participate in PDP QA activities, and drive improvements in manufacturing and post-market quality.

The role requires a strong background in quality assurance, risk management, and regulatory compliance, with excellent communication to collaborate across engineering, manufacturing, and supply chain.