Quality Engineer

Top Echelon LLC; Bay Shore (NY); On-site; USD 70,000 - 110,000; Full time

Job summary

Top Echelon LLC is seeking a Quality Engineer to ensure quality throughout the Product Development Process and lifecycle. You will support Quality Design & Development during design, and sustain manufacturing with root-cause analysis and CAPA implementation.

Responsibilities include risk assessments, design validation, regulatory compliance (ISO, FDA), post-market support, and data-driven continuous improvement. Strong collaboration with engineering and manufacturing is essential.

Qualifications

• Bachelor’s degree or higher in engineering, quality management, or related field.
• Proven experience in quality engineering within manufacturing or product development.
• Strong knowledge of QA methodologies and regulatory requirements.
• Experience with risk management, RCA, CAPA processes.
• Excellent communication and problem-solving skills.
• Certification in quality management (Six Sigma, ASQ CQE) is a plus.

Responsibilities

• Quality Design & Development: support QD&D during PDP and ensure quality requirements are defined and followed.
• PDP: plan and monitor QA measures, conduct risk assessments, design validation and verification.
• Sustaining Manufacturing Support: lead investigations and corrective actions for manufacturing quality issues.
• Product Distribution & Post-Market Support: monitor quality during distribution and assist field teams.
• Compliance & Regulatory: ensure ISO/FDA compliance and prepare documentation for audits.
• Continuous Improvement: drive data-driven improvements in quality processes and systems.
• Collaboration & Communication: work with engineering, manufacturing and supply chain teams.

Skills

Quality assurance methodologies

Regulatory requirements

Risk management

Root cause analysis

Corrective actions

Preventive actions

Communication

Problem-solving

Education

Bachelor’s degree in engineering, quality management, or related field

Job description

As a Quality Engineer, you will play a crucial role in ensuring the highest level of quality standards are met during the Product Development Process (PDP) and throughout the lifecycle of our products. This includes participating in the Quality Design and Development (QD&D) efforts during the initial design phase as well as providing ongoing support for sustaining manufacturing and product distribution. Your focus will be on quality control, assurance, and continuous improvement, ensuring our products meet regulatory requirements and customer expectations.

Key Responsibilities:

• Quality Design & Development:
  Collaborate closely with cross-functional teams to support Quality Design and Development (QD&D) activities during the Product Development Process. Ensure that all quality requirements are clearly defined, implemented, and adhered to throughout the design and development stages.

• Product Development Process (PDP):
  Participate in the planning, execution, and monitoring of quality assurance measures during new product development. Conduct risk assessments, design validation, and verification activities to ensure the product meets design intent and regulatory standards.

• Sustaining Manufacturing Support:
  Provide ongoing quality support to sustaining manufacturing teams. Identify, investigate, and resolve quality issues in manufacturing processes to maintain consistent production standards. Lead root cause analysis and implement corrective actions as needed.

• Product Distribution & Post-Market Support:
  Ensure quality assurance during product distribution and provide support for post-market surveillance activities. Monitor product performance and collaborate with field teams to address any quality concerns that arise in the market.

• Compliance & Regulatory:
  Ensure compliance with all applicable regulatory standards, including ISO, FDA, and other relevant industry regulations. Prepare and maintain required documentation to support regulatory submissions and audits.

• Continuous Improvement:
  Drive continuous improvement initiatives in quality processes, systems, and procedures. Utilize data analysis and metrics to identify areas for improvement and implement effective solutions that enhance overall product quality and efficiency.

• Collaboration & Communication:
  Work closely with engineering, manufacturing, and supply chain teams to foster a culture of quality throughout the organization. Communicate quality expectations clearly and collaborate on best practices to achieve common goals.

Qualifications:

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