Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, Electromechanics, Leadership, Manufacturing, Manufacturing Management, Medical Equipment, Microsoft SharePoint, Organizational Skills, Process Failure Mode and Effects Analysis (PFMEA), Process Quality, Process Validation, Project Planning, Project/Program Coordination, Project/Program Management, Quality Assurance, Quality Management, Support Documentation, 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 Manufacturing Quality 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: Manufacturing Quality Project Manager
Location: Marlborough, MA & Londonderry, NH (Onsite)Job Summary
Seeking an experienced Manufacturing Quality Project Manager with 8+ years of experience in medical device, IVD, or regulated manufacturing environments. This role focuses on leading manufacturing quality projects, coordinating cross-functional teams, and driving process quality initiatives to successful completion.
Key Responsibilities
- Lead manufacturing quality projects across multiple sites.
- Manage project plans, risks, and deliverables using SharePoint and Smartsheet.
- Coordinate with Manufacturing, Validation, Operations, and Quality teams.
- Drive process validation, CAPA, PFMEA, and continuous improvement activities.
- Maintain timelines, resolve roadblocks, and escalate risks as needed.
- Support quality documentation, protocols, reports, and control plans.
Required Qualifications
- 8+ years of project management experience in medical device, IVD, or regulated manufacturing environments.
- Strong knowledge of Process Validation, CAPA, PFMEA, and Control Plans.
- Proven ability to lead cross-functional teams and execute projects.
- Proficiency with SharePoint and Smartsheet.
- Excellent communication, organization, and documentation skills.
Preferred Qualifications
- Experience with Class II IVD diagnostic manufacturing.
- Knowledge of high-volume liquid reagent filling operations.
- Electromechanical medical device manufacturing experience.
- Familiarity with EU IVDR requirements.
Ideal Candidate
Execution-focused project leader with strong organizational skills, capable of driving manufacturing quality initiatives and collaborating effectively in a fast-paced, regulated environment.
Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc
mahalakshmi.n@intellectt.com
Direct: +1 (732) 737 8381