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Senior Manufacturing Quality Engineer (Medical Device)

Job

Intellectt, Inc

Marlborough, MA (In Person)

Full-Time

Posted 2 days ago (Updated 5 hours ago) • Actively hiring

Expires 7/24/2026

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Job Description

Senior Manufacturing Quality Engineer (Medical Device) at Intellectt, Inc Senior Manufacturing Quality Engineer (Medical Device) at Intellectt, Inc in Marlborough, Massachusetts Posted in about 3 hours ago.
Type:
full-time
Job Description:
Position Overview:
Seeking a hands-on Senior Quality Engineer to support manufacturing quality activities in a medical device production environment. This role focuses on production and process quality, working closely with Manufacturing, Validation, and Operations teams to ensure compliant and efficient manufacturing processes.
Key Responsibilities:
Provide day-to-day quality engineering support for manufacturing operations Support production and process controls Lead and support Process Validation and TMV activities Develop and maintain PFMEAs, CAPAs, CPQs, and CTQs Author and update protocols, reports, and quality documentation Partner with Manufacturing Engineering, Validation, and Operations teams
Required Qualifications:
5+ years of Quality Engineering experience in medical device manufacturing Strong experience in production/process quality Experience supporting electromechanical medical devices Hands-on experience with Process Validation, TMV, PFMEA, CAPA, and CPQ/CTQ management Strong technical writing and documentation skills in regulated environments Ability to work on the manufacturing floor and support daily quality activities
Preferred Qualifications:
IVD (In Vitro Diagnostics) product experience Experience with
Agile PLM Ideal Candidate:
Hands-on, execution-focused quality professional Strong independent documentation and problem-solving skills Comfortable working cross-functionally in a fast-paced manufacturing environment