Quality Engineer: Design Quality & Continuous Improvement

True North Consultants, Inc.; Bay Shore (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

True North Consultants, Inc. is seeking a Quality Engineer to ensure top-tier quality throughout the Product Development Process and lifecycle. The role emphasizes QD&D during design, sustaining manufacturing support, post-market surveillance, and regulatory compliance across ISO and FDA standards.

You will collaborate with cross-functional teams to drive risk assessments, design validation, and CAPA initiatives, delivering robust quality improvements and data-driven insights.

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 QA methodologies, product development processes, and regulatory requirements.
• Proficient in risk management, root cause analysis, and corrective/preventive action processes.

Responsibilities

• Support Quality Design and Development (QD&D) activities during PDP to ensure quality requirements are defined and followed.
• Plan, execute, and monitor QA measures during new product development; conduct risk assessments, design validation and verification.
• Provide ongoing quality support to sustaining manufacturing; lead root cause analysis and corrective actions.
• Ensure QA during product distribution and support post-market surveillance activities.
• Ensure compliance with ISO, FDA, and other regulations; prepare documentation for audits.
• Drive continuous improvement using data analysis and metrics to enhance product quality and efficiency.
• Collaborate with engineering, manufacturing, and supply chain to promote a culture of quality.

Skills

Quality assurance

Risk management

Root cause analysis

Regulatory awareness

Education

Bachelor's degree in engineering/quality management

Six Sigma / ASQ CQE certification (optional)

Job description

True North Consultants, Inc. is seeking a Quality Engineer to ensure top-tier quality throughout the Product Development Process and lifecycle. The role emphasizes QD&D during design, sustaining manufacturing support, post-market surveillance, and regulatory compliance across ISO and FDA standards.

You will collaborate with cross-functional teams to drive risk assessments, design validation, and CAPA initiatives, delivering robust quality improvements and data-driven insights.