Quality Engineer - FDA Regulated Products

Ilocatum; Bay Shore (NY); On-site; USD 80,000 - 110,000; Full time

Job summary

Ilocatum is seeking a Quality Engineer to help ensure quality standards throughout the Product Development Process (PDP) and lifecycle of our products, with involvement in QD&D during design and ongoing support for manufacturing and distribution.

You will lead risk assessments, design validation/verification, root cause analysis, and CAPA to meet regulatory requirements and customer expectations, while collaborating with engineering, manufacturing, and supply chain to drive continuous

Qualifications

• Bachelor's degree in engineering, quality management, or related field.
• Experience as a Quality Engineer in manufacturing or product development.
• Strong knowledge of QA methodologies, PDP, and regulatory requirements.
• Proficient in risk management, root cause analysis, and CAPA.
• Excellent communication and problem-solving skills.
• Quality management certification is a plus (Six Sigma or CQE).

Responsibilities

• Support QD&D during PDP design phase and ensure quality requirements are defined.
• Plan, execute, and monitor QA measures during new product development.
• Provide sustaining manufacturing quality support and RCA/corrective actions.
• Ensure QA during product distribution and post-market surveillance.
• Maintain regulatory documentation for audits and submissions.
• Drive continual quality improvement using data and metrics.
• Collaborate with engineering, manufacturing, and supply chain to promote quality.

Skills

Quality engineering

Risk management

Root cause analysis

Regulatory knowledge

Problem solving

Communication

Education

Bachelor's degree in Engineering

Tools

Six Sigma tools

CAPA processes

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.