Biogensys
Princeton, NJ
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Job Description :

We are hiring a Quality Engineer for one of our clients in Hartford, CT.

Job Description:

  • FDA -21 CFR 820-198 experience
  • QMS implementation experience
  • Manufacturing Experience with Medical Industry Components.
  • Provide support to the engineering, manufacturing, logistics, and quality functions within a team participation setting
  • Document and communicate the results of problem solutions and conduct analytical examinations to both internal and external customers
  • Advocate the usage of quality improvement and control tools
  • Update and develop quality documents where required

Skills Required:

  • Ability and Knowledge to conduct Root Cause Analysis through various industrial techniques. 8D, A3, DMAIC
  • Ability to develop and execute: Risk assessments, Validation plans, DFMEA’s / PFMEA’s, Control Plans, Measurement System Analysis, Process Flow Diagrams, First Article Inspections.
  • Knowledge of Statistical Process Control Techniques

Experience Required:

  • 3 - 5 years of experience in an engineering or quality related position
  • Experience with Medical Industry Standards, submittals and execution. IQ, OQ, PQ, TMV’s, ISO13485
  • Experience in the development and execution of standard operating procedure documents
  • Experience with DOE Matrix development
  • PC proficiency with Minitab, Excel
  • Test Method Validation development and execution experience
  • Experience with executing variable and attribute Gage R&R’s
  • Practical experience with GD&T standards and implementation

About Us:

We are specialized in recruiting and deliver the best professional talent of industry and we are committed to deliver best experience for our clients and job seekers. With over two decades of experience in the recruitment industry, we proudly help you to find the next job that matches your professional skills. Our team understands your needs or requirement before starting the recruitment, that enables to find the high quality of talent with high success rate of talent delivery, keeps us continue to be the best in the industry.

             

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