Quality Engineer - Design, Compliance & Continuous Improvement

Tom Trese Networking LLC; Bay Shore (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

Tom Trese Networking LLC is seeking a Quality Engineer to guarantee high quality throughout the Product Development Process and lifecycle. You will contribute to Quality Design & Development (QD&D) during design and provide ongoing support for sustaining manufacturing, distribution, and post-market activities.

Responsibilities include leading risk assessments, design validation, root-cause analysis, CAPA, and regulatory compliance with ISO and FDA standards, while driving continuous improvement

Qualifications

• Bachelor’s degree in engineering, quality management, or related field.
• Proven experience as a Quality Engineer in manufacturing or product development.
• Strong knowledge of QA methodologies, development processes, and regulatory requirements.
• Proficient in risk management, root cause analysis, and CAPA processes.
• Excellent communication and problem-solving skills.
• Six Sigma or ASQ Certified Quality Engineer is a plus.

Responsibilities

• Quality Design & Development (QD&D) collaboration with cross-functional teams throughout design and development.
• Plan, execute, and monitor QA measures in new product development to ensure design intent and regulatory standards.
• Support sustaining manufacturing teams by leading root cause analysis and implementing corrective actions.
• Ensure quality during product distribution and assist with post-market surveillance activities.
• Maintain compliance with ISO, FDA, and relevant regulations and prepare required documentation.
• Drive continuous improvement in quality processes and metrics to enhance product quality and efficiency.
• Collaborate with engineering, manufacturing, and supply chain teams to promote a culture of quality.

Skills

Quality assurance

Regulatory knowledge

Risk management

Root cause analysis

Communication skills

Problem solving

Education

Bachelor's degree in engineering or related field

Job description

Tom Trese Networking LLC is seeking a Quality Engineer to guarantee high quality throughout the Product Development Process and lifecycle. You will contribute to Quality Design & Development (QD&D) during design and provide ongoing support for sustaining manufacturing, distribution, and post-market activities.

Responsibilities include leading risk assessments, design validation, root-cause analysis, CAPA, and regulatory compliance with ISO and FDA standards, while driving continuous improvement