Senior Quality Engineer

Hello,

I hope you're doing well.

My name is
Purna
, and I'm reaching out from Intellectt Inc regarding an exciting contract opportunity for a
Senior 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.

Senior Quality Engineer

Location:

North Haven, CT (Onsite)

Seeking a Senior Quality Engineer with experience in medical device quality systems, process validation, CAPA, and regulatory compliance
. The ideal candidate will support manufacturing quality, investigations, process improvements, and validation activities while ensuring compliance with FDA and ISO requirements.

• Support manufacturing quality and product quality improvements.
• Lead investigations for NCRs, CAPAs, deviations, and customer complaints.
• Perform root cause analysis using tools such as 5 Why, Fishbone, and PFMEA
  .
• Support IQ/OQ/PQ
  , process validation, and equipment qualification.
• Review and approve validation protocols, engineering changes, and quality documentation.
• Conduct risk assessments and participate in DFMEA/PFMEA activities.
• Collaborate with Manufacturing, R&D, Regulatory, and Supplier Quality teams.
• Ensure compliance with FDA, ISO 13485, and quality management system requirements.

• Bachelor's degree in Engineering or related technical field.
• 4+ years of Quality Engineering experience in a regulated manufacturing environment.
• Experience with CAPA, NCR, Root Cause Analysis, Process Validation, Change Control, and Risk Management
  .
• Strong knowledge of statistical analysis and quality improvement tools.

• Medical device manufacturing experience.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, Minitab, SPC, DOE, and Lean Six Sigma
  .
• Experience supporting audits, supplier quality, and continuous improvement initiatives.