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 ensure product quality across the entire lifecycle, from design through sustaining manufacturing and post-market support.

You will lead Quality Design & Development, participate in PDP QA activities, drive root-cause analysis and corrective actions, ensure regulatory compliance (ISO/FDA), and collaborate with engineering, manufacturing, and supply chain teams to foster a culture of quality.

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 CAPA processes.
• Excellent communication and problem-solving skills.
• Certification in quality management systems (e.g., Six Sigma, ASQ CQE) is a plus.

Responsibilities

• Quality Design & Development: support QD&D activities during PDP and ensure quality requirements are met.
• Participate in PDP planning, execution, and monitoring of QA measures to meet standards.
• Sustaining Manufacturing Support: identify, investigate, and resolve quality issues; lead root cause analysis and corrective actions.
• Product Distribution & Post-Market Support: assure QA during distribution and support post-market surveillance.
• Compliance & Regulatory: ensure ISO/FDA compliance and prepare documentation for audits.
• Continuous Improvement: use data analysis to drive improvements in processes, systems, and quality.
• Collaboration & Communication: work with engineering, manufacturing, and supply chain to promote quality.

Skills

Quality assurance knowledge

Risk management

Root cause analysis

Communication skills

Problem-solving skills

Education

Bachelor’s degree in engineering, quality management, or related field

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.