Sr. Quality Engineer
Intellectt INC
North Haven, CT
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JOB DETAILS
SKILLS
Change Control, Code of Federal Regulations, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Design Failure Mode and Effects Analysis (DFMEA), Documentation, Engineering, Equipment Validation, FDA (Food and Drug Administration), FDA Requirements, Healthcare Quality, ISO (International Organization for Standardization), Lean Six Sigma, Maintain Compliance, Manufacturing, Medical Equipment, Minitab, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Process Validation, Quality Engineering, Quality Management, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Research & Development (R&D), Risk Analysis, Risk Management, Root Cause Analysis, Statistics, System Validation, United States Department of Energy (DOE), Validation Plan, Vendor/Supplier Evaluation
LOCATION
North Haven, CT
POSTED
1 day ago
Hi ,
Hope you are doing good,
My name is Ayaan, and I'm a Senior Recruiter at Intellectt Inc. I came across your profile and believe your experience could be a good match for an exciting opportunity I'm currently working on.
If you're interested, please send your updated resume to ayaan.f@intellectt.com
Role: Sr. Quality Engineer
Location: North Haven, CT (Onsite)
Durations: Long-Term
Location: North Haven, CT (Onsite)
Durations: Long-Term
Job Summary
Seeking a Sr. 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.
Seeking a Sr. 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.
Key Responsibilities:
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.
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.
Required Qualifications
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.
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.
Preferred Qualifications
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.
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.
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+1 732-355-7246
517 Route 1 South, Suite 2103,
About the Company
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