Sr. Quality Engineer

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

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