Quality Engineer - PDP, QD&D & Continuous Improvement

Ashton North LLC; Bay Shore (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

Ashton North LLC is seeking a Quality Engineer to drive quality across the product lifecycle in its New York operations. You will influence QD&D during design, support PDP activities, and lead root-cause investigations to sustain manufacturing quality.

The role emphasizes regulatory compliance with ISO and FDA standards, post-market surveillance collaboration, and ongoing continuous-improvement initiatives to enhance product quality and efficiency.

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, PDP, and regulatory requirements.
• Certification in Six Sigma or ASQ Certified Quality Engineer is a plus.

Responsibilities

• Quality Design & Development: Collaborate with cross-functional teams to support QD&D during the PDP.
• Product Development Process: Plan, execute, and monitor quality assurance measures for new product development.
• Sustaining Manufacturing Support: Provide ongoing quality support to manufacturing teams; lead root cause analysis.
• Product Distribution & Post-Market Support: Ensure QA during distribution and support post-market surveillance.
• Compliance & Regulatory: Ensure compliance with ISO, FDA and other regulations; prepare regulatory submissions.
• Continuous Improvement: Drive improvements using data analysis and metrics.
• Collaboration & Communication: Work with engineering, manufacturing, and supply chain to promote quality.

Skills

Quality assurance

Risk management

Root cause analysis

Communication

Problem solving

Six Sigma

Education

Bachelor’s degree in engineering or quality management

Job description

Ashton North LLC is seeking a Quality Engineer to drive quality across the product lifecycle in its New York operations. You will influence QD&D during design, support PDP activities, and lead root-cause investigations to sustain manufacturing quality.

The role emphasizes regulatory compliance with ISO and FDA standards, post-market surveillance collaboration, and ongoing continuous-improvement initiatives to enhance product quality and efficiency.