Sr. Quality Engineer

3 days ago


Marlborough, United States The Judge Group Full time

Industry: Medical Device

Title: Sr. Quality Engineer - Medical Device

Location: Marlborough, MA (Fully On-Site)

Duration: 6+ months contract

Responsibilities:

  • Support Material nonconformance investigation and disposition activity, participate in weekly MRB meetings, follow-up on supplier issues
  • Assist with maintenance of calibration system
  • Support Manufacturing Engineering in the creation, release and maintenance of DHR, routers, bills of material, and specifications for manufacturing
  • Support Product development activities and design transfer into manufacturing
  • Perform incoming inspection review and disposition of product components and subsystems
  • Develop and/or revise routine procedures, work instructions, and test methods.
  • Document all activities in compliance with applicable medical standards, regulations, and guidelines.
  • Assist in investigations of quality issues arising from product complaints, CAPAs, and non-conforming reports.
  • Support management of new and approved suppliers; participate in internal and supplier audits.
  • Utilize problem solving tools to analyze and identify root causes and implement corrective actions.
  • Make decisions and propose solutions based on calculated risks identified through data analysis.


Requirements:

  • 5 - 10 years of manufacturing quality experience within the medical device industry.
  • Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred.
  • Extensive working knowledge of 21 CFR 820 and ISO 13485.
  • Strong working knowledge of Microsoft Word and Excel.
  • Hands-on experience with any of the following manufacturing processes: Electro-mechanical assembly, ESD controls, Cabling, Clean room, Labeling, sterilization.
  • Experience executing process validation and test method validation/Gage R&R activities.
  • Strong documentation capability for protocol and report generation and review.
  • Prior start-up experience is a plus.


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