Quality Engineer: Design-Driven QA & Compliance Leader

Keystone Distinction Group; Bay Shore (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

Keystone Distinction Group is seeking a Quality Engineer to strengthen our Product Development Process with a focus on Quality Design & Development (QD&D), risk management, and regulatory compliance in manufacturing.

You will drive continuous improvement, support sustaining manufacturing, and assist in post-market surveillance, audits, and CAPA implementation. This role requires strong problem-solving and communication skills and a Bachelor’s degree in engineering.

Qualifications

• Bachelor's degree in engineering or related field.
• Experience as a Quality Engineer in manufacturing or product development.
• Knowledge of QA methodologies, regulatory requirements (ISO, FDA).
• Proficient in risk management, RCA, CAPA processes.
• Excellent communication and problem-solving skills.
• Six Sigma/ASQ CQE certification a plus.

Responsibilities

• Support Quality Design & Development (QD&D) during the Product Development Process (PDP) to define and implement quality requirements.
• Participate in planning, execution, and monitoring of QA measures, including risk assessments, design validation and verification.
• Provide ongoing quality support to sustaining manufacturing, lead root cause analysis and implement corrective actions.
• Ensure quality during product distribution and support post-market surveillance activities.
• Ensure compliance with ISO, FDA and other regulatory standards; prepare documentation for audits.
• Drive continuous improvement using data analysis and metrics to enhance product quality and efficiency.
• Collaborate with engineering, manufacturing and supply chain to promote a culture of quality.

Skills

Quality Assurance

Risk Management

Root Cause Analysis

Communication

Problem Solving

Education

Bachelor’s degree in engineering

Job description

Keystone Distinction Group is seeking a Quality Engineer to strengthen our Product Development Process with a focus on Quality Design & Development (QD&D), risk management, and regulatory compliance in manufacturing.

You will drive continuous improvement, support sustaining manufacturing, and assist in post-market surveillance, audits, and CAPA implementation. This role requires strong problem-solving and communication skills and a Bachelor’s degree in engineering.