Quality Engineer

Location: Bay Shore, NY |
Schedule: Full-time, on-site

An established manufacturer is seeking a Quality Engineer to play a crucial role in ensuring the highest level of quality standards are met throughout the Product Development Process (PDP) and across the full lifecycle of its products. This includes participating in Quality Design and Development (QD&D) efforts during the initial design phase, as well as providing ongoing support for sustaining manufacturing and product distribution.

The focus of this role is on quality control, assurance, and continuous improvement, ensuring products meet regulatory requirements and customer expectations.

• 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
• 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 products meet design intent and regulatory standards
• 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
• Ensure quality assurance during product distribution and provide support for post-market surveillance activities
• Monitor product performance and collaborate with field teams to address quality concerns that arise in the market
• 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
• 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
• 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

• 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

This position offers the opportunity to influence product quality across the full lifecycle—from initial design through sustaining manufacturing and post-market support—while ensuring compliance with regulatory standards such as ISO and FDA requirements and driving continuous improvement in a manufacturing environment.