Quality Engineer 3

  • Location

    Tarrytown, United States

  • Sector:

    Business Professional

  • Job type:


  • Contact:

    Sonu Chouhan

  • Job ref:


  • Published:

    over 1 year ago

  • Expiry date:


This is a contractor position for a Quality Engineer with strong corrective and preventive action (CAPA) process experience for post-market medical devices. This role is expected to provide leadership and technical support for CAPAs or is a key contributor to cross functional process improvement and problem solving teams. Key responsibilities include:

  • Ensures compliance to regulatory requirements per CFR 820, ISO 23485, CDMR and other applicable regulations, company procedures for CAPA systems.
  • Supports Quality management, which includes ensuring that CAPAs are issued as required, properly investigated, documented, and completed on time.
  • Communicates obstacles, provides solutions and leads implementation of new opportunities for improvements to work processes, production, QA review and other areas as identified.


  • Trains assigned individuals in root cause analysis tools to ensure correct root cause identification, appropriate action plan identification and effectiveness verification are achieved.
  • Manages quality metrics, leads corrective action review board, and develops meeting outcomes to ensure continual improvement of the CAPA process.

Required Knowledge/Skills, Education, and Experience

  • BS Engineering, Science or related field is required.
  • 5+ year medical device or pharmaceutical industry experience.
  • Must have experience with 21 CFR 820.
  • Ability to analyze and solve complex problems as well as the ability to communicate effectively across departments is crucial in this role.
  • Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.

Preferred Knowledge/Skills, Education, and Experience

  • CQE or CQA is desirable.
  • Previous experience supervising technicians and conducting and participating in FDA / customer / corporate audits is preferred.
  • Ability to use MS Office products along with statistical software proficiency is preferred.
  • Proficiency in statistical analysis.