Quality Engineer

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

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.