Job: #16074 – Supplier Quality Engineer

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Company Type



Farmingdale, New York

Job Description

  • Perform regular supplier audits to ensure regulatory compliance.
  • Monitor and improve supplier quality and process performance.
  • Facilitate and perform on-site visits for root cause analysis.  Implement and verify corrective actions of supplier quality issues.
  • Create, monitor, and present supplier quality performance metrics
  • Maintain accurate quality records for supplier management.
  • Develop new approaches to solve problems identified during quality assurance activities.  Assists or leads activities/projects to improve the Quality Management System including coordinating, development, training and maintenance.  
  • Review customer complaints, conduct product investigations, and ensure proper complaint closure.
  • Conduct medical device reporting assessments and process potential MDR reports
  • Ideal candidate should possess good problem solving & logical decision-making abilities
  • Develop sampling plans for evaluating, and reporting quality and reliability data
  • Demonstrate continuous effort to improve product quality and manufacturing processes.
  • Work with Quality Control to streamline incoming inspection process.

Job Skills

  • 5-7 years in manufacturing industry in Quality functions in an FDA regulated or equivalent industry.  Experience in medical device industry highly desirable.  Experience in Supplier Management.
  • Working knowledge of FDA regulations, cGMP, US-FDA’s 21 cfr part 820, and ISO 13485:2016.
  • Strong MS office skills
  • Excellent communication, interpersonal skills, teamwork and problem solving skills.
  • Bachelors degree in Engineering preferred

Job ID: 16074


Engineer, Northeast