Sr. Quality Engineer - Medical Device at The Judge Group Inc. in Marlborough, Massachusetts

Job Description:

Location: Marlborough, MA

Salary: Negotiable

Description: Our client is currently seeking a Sr. Quality Engineer - Medical Device/ON SITE position

***All candidates must live in the Metro-Boston & Rhode Island area***



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.


• 
  MUST have Class II (preferred) or Class III Medical Device experience THIS IS A MUST HAVE
  

Contact: psalvatore@judge.com


This job and many more are available through The Judge Group. Find us on the web at www.judge.com Apply Now