Intellectt Inc · 3 hours ago
Quality Engineer – Medical Devices
North Carolina, United States
Contract
Onsite
Mid, Senior Level
3+ years expIntellectt Inc is seeking a Quality Engineer to support quality systems and compliance activities for medical device development and manufacturing. This role will collaborate with various teams to ensure products meet regulatory requirements and internal quality standards.
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Hiring Manager
Rithik Chawda
Responsibilities
Support and maintain Quality Management System (QMS) in compliance with FDA 21 CFR 820 and ISO 13485
Participate in design controls , including reviews, DHF documentation, and change management
Lead or support CAPA, deviations, nonconformances , and root cause investigations
Support risk management activities (ISO 14971, DFMEA/FMEA)
Review and approve quality documentation including SOPs, protocols, reports, and validation documentation
Support internal and external audits and inspection readiness activities
Partner with cross-functional teams to ensure quality requirements are embedded in product development and manufacturing
Support supplier quality activities, including qualification, audits, and issue resolution
Track and trend quality metrics and support continuous improvement initiatives
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
3–7+ years of experience as a Quality Engineer in the medical device industry
Strong working knowledge of FDA 21 CFR 820, ISO 13485, and QMS processes
Hands-on experience with CAPA, deviations, complaints, and change control
Experience with risk management (ISO 14971, FMEA/DFMEA)
Excellent documentation, communication, and cross-functional collaboration skills
Preferred
Experience supporting design verification/validation (V&V) activities
Familiarity with MDR/IVDR and global regulatory requirements
Experience with QMS tools (e.g., TrackWise, MasterControl, Veeva)
Audit experience (internal audits or supplier audits)
Exposure to manufacturing process validation or CSV
Company
Intellectt Inc
Intellectt Inc.
1001-5000 employees
H1B Sponsorship
Intellectt Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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2025 (271)
2024 (255)
2023 (312)
2022 (372)
2021 (217)
2020 (134)
Funding
Current Stage
Late StageCompany data provided by crunchbase