Quality Engineer
  • Saint Paul, Minnesota, US
  • +914043515100
456 Days ago
Job Description


This is Venkat from Intellectt Inc. Please find the below position and let me know your response.

Role: Quality Engineer

Location: MN, MA, CA

Duration: 18+ Months

Experience: 1+ Years


  • These activities must be under FDA Quality System Regulation, ISO13485, and other international standards. This position will also support device complaint investigation and failure analysis as required

Essential Duties and Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review.
  • Complete final acceptance activities. Manage the sterilization process, including validations and product sterile loads.
  • Track nonconforming material and lead Material Review Board (MRB) efforts.
  • Interface and take lead QA role in interactions with suppliers, contractors, and consultants that supply components, subassemblies, and contract processing.
  • Lead complaint investigations on the returned product. Manage corrective action and quality improvement activities.
  • Manage aspects of the internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing.
  • Support quarterly management review meetings. Establish, monitor, and evaluate quality system metrics.
  • Looking for strong line engineering candidates. Familiar with DMAIC processes and Root Cause Analysis. Will be involved with supporting manufacturing floors, participation in operational excellence, and documenting CAPA's.

Thanks & Regards

Venkat | Recruiter

+1 732-631-8229
517 Route 1 South, Suite 1115 Iselin, NJ 08830.
  • NA

Required Skills
  • CAPA,ISO13485,Medical Device,Quality engineer

  • 1+ Years of Experience

  • NA

Working Hours / Week
  • 40h