Job: #16215 – Quality Engineer

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Company Type



Farmingdale, New York

Job Description

  • Review customer complaints, conduct product investigations, and ensure proper complaint closure
  • Conduct medical device reporting assessments and investigations.
  • 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.
  • Participates on Project Team as Quality Representative.  Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
  • Provides Quality Assurance leadership for Project Teams or Quality Department.
  • Creates, reviews and approves Quality System Documents (ex. CAPA, Audits).
  • Creates, reviews and approves Product Documents.
  • Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documents.
  • Mentors entry point staff.
  • Provides supervision to technicians and entry level engineers.
  • Assists in the review and interviews of potential candidates. 
  • Creates, reviews and approves documents required for Design History File.
  • Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA.
  • Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans.
  • Performs Internal or Supplier Quality System Audits.
  • Ensures compliance to Department procedures.
  • Tracks and trends Quality Indicators.
  • Serves as Independent QA Reviewer and Chairperson for Design Reviews.

Job Skills

  • Quality Engineering and Customer Complaint Investigation experience    
  • Working knowledge of standards and regulations, including but not limited to US-FDA’s 21 CFR Part 820 and 21 CFR Part 803, and GMP.
  • Medical Device Industry experience and working knowledge of ISO-13485 preferred Quality management systems, and ISO 14971 Medical devices 
  • Demonstrated good written and oral communication skills
  • Proficiency in Microsoft Office package
  • Experience in root cause analysis and problem solving techniques
  • Knowledge of basic quality tools, risk analysis & statistics 
  • BS degrees in an engineering/scientific or quality management curriculum.  
  • A minimum of 5 – 7 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
  • Experience in the development and implementation of effective Design Control Systems.

Job ID: 16215


Engineer, Northeast