Quality Engineer: Design, Improve & Ensure Compliance

Job Juncture; Bay Shore (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

Job Juncture is seeking a Quality Engineer to ensure top-quality standards throughout the Product Development Process and lifecycle of our products. You will support QD&D during design and provide ongoing quality assurance for manufacturing and distribution.

Responsibilities include design validation, risk assessments, CAPA, post-market surveillance, and regulatory compliance with ISO and FDA standards. Strong collaboration with engineering, manufacturing, and supply chain is required.

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.

Responsibilities

• Quality Design & Development: Collaborate with cross-functional teams to support QD&D activities during PDP. Ensure all quality requirements are defined, implemented, and adhered to throughout design and development stages.
• PDP: Plan, execute, and monitor quality assurance measures during new product development; conduct risk assessments, design validation, and verification.
• Sustaining Manufacturing Support: Provide ongoing quality support to manufacturing; lead root cause analysis and implement corrective actions.
• Product Distribution & Post-Market Support: Ensure QA during product distribution and support post-market surveillance.
• Compliance & Regulatory: Ensure ISO, FDA, and other regulatory standards; maintain documentation for submissions and audits.
• Continuous Improvement: Drive improvements in quality processes, systems, and procedures using data analysis.
• Collaboration & Communication: Work with engineering, manufacturing, and supply chain to promote a culture of quality.

Skills

Quality Assurance

Product Development

Regulatory Knowledge

Risk Management

Root Cause Analysis

CAPA

Communication

Problem Solving

Six Sigma

Education

Bachelor's degree in engineering, quality management, or a related field

Job description

Job Juncture is seeking a Quality Engineer to ensure top-quality standards throughout the Product Development Process and lifecycle of our products. You will support QD&D during design and provide ongoing quality assurance for manufacturing and distribution.

Responsibilities include design validation, risk assessments, CAPA, post-market surveillance, and regulatory compliance with ISO and FDA standards. Strong collaboration with engineering, manufacturing, and supply chain is required.