Hello,
I hope you’re doing well.
My name is Vyshu, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Senior Manufacturing Quality Engineer based in Marlborough, MA 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 vyshnavi.t@intellectt.com
Role: Senior Manufacturing Quality Engineer (Medical Device / IVD)
Location: Marlborough, MA
Overview:
Seeking a hands-on Senior Manufacturing Quality Engineer to support manufacturing quality activities for medical devices, with a strong preference for IVD (In Vitro Diagnostics) experience. This role partners closely with Manufacturing, Validation, and Operations teams to ensure compliant, efficient, and high-quality production processes.
Key Responsibilities:
- Provide day-to-day quality engineering support for manufacturing operations.
- Support production and process quality activities on the manufacturing floor.
- Lead and support Process Validation and TMV activities.
- Develop and maintain PFMEAs, CAPAs, CPQs, and CTQs.
- Author and update protocols, reports, and quality documentation.
- Collaborate with Manufacturing Engineering, Validation, and Operations teams to drive quality improvements and compliance.
Required Qualifications:
- 5+ years of Quality Engineering experience in medical device manufacturing.
- Strong background in production and process quality.
- Experience supporting electromechanical medical devices.
- Hands-on expertise with Process Validation, TMV, PFMEA, CAPA, and CPQ/CTQ management.
- Strong technical writing and documentation skills in regulated environments.
- Ability to work independently and support daily manufacturing quality activities.
Preferred Qualifications:
- IVD (In Vitro Diagnostics) product experience strongly preferred.
- Experience with Agile PLM.
Ideal Candidate:
- Hands-on, execution-focused quality professional.
- Strong problem-solving and documentation skills.
- Comfortable working cross-functionally in a fast-paced manufacturing environment.
Thanks & Regards,
Vyshnavi
Recruiter
Intellectt Inc
vyshnavi.t@intellectt.com
Direct: 732 204 6550
Desk number: 732 412 6999 - Ext: 225