Quality Engineer

True North Consultants, Inc.; Bay Shore (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

True North Consultants, Inc. is seeking a Quality Engineer to ensure top-tier quality throughout the Product Development Process and lifecycle. The role emphasizes QD&D during design, sustaining manufacturing support, post-market surveillance, and regulatory compliance across ISO and FDA standards.

You will collaborate with cross-functional teams to drive risk assessments, design validation, and CAPA initiatives, delivering robust quality improvements and data-driven insights.

Qualifications

• Bachelor’s degree in engineering, quality management, or a related field.
• Proven experience as a Quality Engineer in manufacturing or product development.
• Strong knowledge of QA methodologies, product development processes, and regulatory requirements.
• Proficient in risk management, root cause analysis, and corrective/preventive action processes.

Responsibilities

• Support Quality Design and Development (QD&D) activities during PDP to ensure quality requirements are defined and followed.
• Plan, execute, and monitor QA measures during new product development; conduct risk assessments, design validation and verification.
• Provide ongoing quality support to sustaining manufacturing; lead root cause analysis and corrective actions.
• Ensure QA during product distribution and support post-market surveillance activities.
• Ensure compliance with ISO, FDA, and other regulations; 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

Regulatory awareness

Education

Bachelor's degree in engineering/quality management

Six Sigma / ASQ CQE certification (optional)

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.