Sr. Quality Engineer Job at Intellectt INC, North Haven, CT

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  • Intellectt INC
  • North Haven, CT

Job Description

Hello,

I hope you're doing well.

My name is Mahalakshmi, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Sr. Quality Engineer based in North Haven, CT (Onsite) with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at mahalakshmi.n@intellectt.com OR +1 (732) 737 8381



Job Title: Sr. Quality Engineer
Location: North Haven, CT (Onsite)

Job Description:

We are seeking a Sr. Quality Engineer with 4+ years of experience in medical device quality systems and regulated manufacturing . The ideal candidate will have expertise in CAPA, NCR, process validation, root cause analysis, risk management, and FDA/ISO compliance to support manufacturing quality and continuous improvement.

Required Skills:

  • CAPA, NCR & Change Control
  • IQ/OQ/PQ & Process Validation
  • Root Cause Analysis (5 Why, Fishbone, PFMEA)
  • Risk Management & DFMEA/PFMEA
  • Statistical Analysis, SPC & DOE
  • FDA 21 CFR Part 820 & ISO 13485

Preferred:

  • Medical Device Manufacturing
  • ISO 14971, EU MDR, Minitab
  • Lean Six Sigma, Supplier Quality & Audit Support

Education: Bachelor's degree in Engineering or a related technical field.


Thanks & Regards,
Mahalakshmi

Junior Recruiter
Intellectt Inc

mahalakshmi.n@intellectt.com

Direct: +1 (732) 737 8381














Job Tags

Contract work

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