Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Electromechanics, FDA (Food and Drug Administration), FDA Requirements, Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Leadership, Manufacturing, Manufacturing Management, Manufacturing/Industrial Processes, Medical Equipment, Microsoft SharePoint, Process Failure Mode and Effects Analysis (PFMEA), Process Validation, Project Execution, Project/Program Management, Quality Engineering, Root Cause Analysis, Team Lead/Manager
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 Quality Engineer / Project Manager based in Marlborough, MA & Londonderry, NH (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: Quality Engineer / Project Manager
Location: Marlborough, MA & Londonderry, NH (Onsite)Job Summary
Seeking an experienced Quality Engineer / Project Manager to support manufacturing quality and process validation activities for Class II IVD and electromechanical medical devices. This role focuses on project execution, quality remediation, and cross-functional coordination in an FDA-regulated manufacturing environment.
Key Responsibilities
- Lead manufacturing quality projects across multiple sites.
- Drive IQ/OQ/PQ validations, CAPA, NCR, and continuous improvement activities.
- Support PFMEA/FMEA, Control Plans, Deviations, and Root Cause Analysis.
- Track timelines, risks, and deliverables using SharePoint and Smartsheet.
- Collaborate with Manufacturing, Validation, Operations, and Quality teams to ensure project success.
Required Qualifications
- 5+ years of experience in Medical Device, IVD, or regulated manufacturing.
- Strong knowledge of Manufacturing Quality and Process Validation (IQ/OQ/PQ).
- Hands-on experience with CAPA, PFMEA/FMEA, NCRs, Deviations, and Root Cause Analysis.
- Proven Project Management experience leading cross-functional teams.
- Proficiency with SharePoint and Smartsheet.
Preferred
- Class II Medical Device or IVD manufacturing experience.
- Electromechanical device manufacturing background.
- Knowledge of ISO 13485, FDA regulations, GMP, and EU IVDR.
Key Skills
Medical Device | IVD | Process Validation (IQ/OQ/PQ) | CAPA | PFMEA/FMEA | NCR | Root Cause Analysis | Project Management | SharePoint | Smartsheet