Connecting...

W1siziisijiwmtkvmdevmtcvmdkvntkvndmvmtu0l2vuz2luzwvyaw5nmi5qcgcixsxbinailcj0ahvtyiisijiwmdb4nzawiyjdxq
Job

Quality Engineer

  • Job ref:

    11199

  • Location:

    Bedford, United States

  • Sector:

    Quality Engineers

  • Contact:

    Lissa Jerez

  • Published:

    6 months ago

  • Consultant:

    Lissa Jerez

Main Responsibilities:

  • Providing support to QA/QC, R&D, Manufacturing departments to ensure products are developed, manufactured, delivered, and serviced in compliance with regulations and customer needs
  • Developing Quality Plans for inspection and test of incoming parts, components, assemblies, systems, products.
  • Developing methods for Quality process control measurements and inspections
  • Working with R&D to manage, gather, assemble, author and audit for accuracy and completeness of documentation throughout NPI / product lifecycle 
  • Providing leadership in product Risk Management
  • Assessing and monitoring supplier controls
  • Monitoring process performance and process capabilities, gather relevant data, identify quality trends, produce statistical reports and summarize findings for review and action
  • Performing, monitoring, analyzing and reporting inspection/testing results and quality data, metrics, and trending.
  • Developing and implementing SPC programs
  • CAPAs, complaints, vigilance monitoring, investigations and procedure writing

EXPERIENCE

  • Minimum 3 – 5 years of Quality experience in the life sciences industry preferably with medical devices and or in
  • bioprocess equipment and methods.
  • Working knowledge of manufacturing processes, including but not limited to the manufacture of complex
  • electro-mechanical equipment, capital equipment for Medical, Industrial and semiconductor industry.
  • Experience in hardware, software, product development, verification, and validation
  • Experience with six sigma, lean
  • Good communication and technical writing skills
  • Ability to thrive in a dynamic small / startup environment
  • Experience with mechanical, electrical inspection
  • Strong working knowledge with electrical and mechanical test equipment: Height gage, micrometer, dial indicators, gauges, mechanical and electrical measuring equipment, calipers, optical comparator, oscilloscope

EDUCATION

• BS/BA in Sciences or Technical Discipline preferred