Quality Engineer

Red Seal Recruiting; Bay Shore (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

Red Seal Recruiting is seeking a Quality Engineer to drive quality in the Product Development Process and through the product lifecycle, ensuring regulatory compliance and customer satisfaction.

You will lead QD&D efforts, perform risk assessments, support manufacturing, oversee post-market surveillance, and promote continuous improvement across engineering, manufacturing, and supply chain. A bachelor’s degree and QA experience are required, with Six Sigma or CQE certification a plus.

Qualifications

• Bachelor's degree in engineering or quality management or related field.
• Proven experience as a Quality Engineer in manufacturing or product development.
• Knowledge of QA methodologies, regulatory standards and risk management.
• Experience with CAPA processes and root cause analysis.
• Strong communication and problem-solving skills.
• Certification in quality management (Six Sigma or ASQ CQE) is a plus.

Responsibilities

• Quality Design & Development: collaborate with cross-functional teams on QD&D activities.
• Product Development Process: plan and monitor QA measures, perform risk assessments and validation.
• Sustaining Manufacturing Support: investigate quality issues, lead root cause analysis, implement corrective actions.
• Product Distribution & Post-Market: ensure QA during distribution and support post-market surveillance.
• Compliance & Regulatory: ensure ISO, FDA and applicable regulatory compliance and documentation.
• Continuous Improvement: drive improvements using data analysis and metrics.
• Collaboration & Communication: align with engineering, manufacturing and supply chain to promote quality.

Skills

Quality design

Risk management

Root cause analysis

CAPA

Communication

Problem solving

Regulatory knowledge

Six Sigma

ASQ CQE

Education

Bachelor's degree in engineering or related field

Tools

FMEA

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.