Kaztronix LLC · 3 hours ago
Senior Quality Engineer
Massachusetts, United States
Contract
Onsite
Senior Level
5+ years expKaztronix LLC is seeking a Senior Quality Engineer to support new product development, process validation, and manufacturing activities for Class III devices. This role requires strong statistical skills and collaboration across engineering, operations, and quality teams.
ConsultingInformation TechnologyStaffing Agency
Hiring Manager
Danny Wolford
Responsibilities
Interpret engineering drawings, CMM data, and dimensional reports (ASME Y14.5M / GD&T)
Perform statistical analysis using Excel and Minitab; support reliability and data‑driven decision making
Lead development of product requirements, verification plans, and validation strategies
Execute and document IQ/OQ/PQ/PVE activities; write and review validation protocols and reports
Serve as QA representative for NPD; ensure compliance with GMP, ISO 13485, ISO 14971, and FDA 21 CFR 820
Conduct internal audits and support external audit readiness
Manage quality documentation (NCs, CAPA, PFMEA/DFMEA, Gage R&R, TMV, Control Plans, SOPs)
Lead or support product/process launches and transfer validations
Apply structured root‑cause tools (A3, 5‑Whys) and perform hands‑on troubleshooting
Collaborate with cross‑functional teams and provide project leadership
Qualification
Required
B.S. in Engineering
5+ years in medical devices (orthopedics preferred)
Experience in Quality Engineering and/or Validation for Class III devices
Proficiency with MS Office and Minitab
Strong statistical, analytical, and problem‑solving skills
Effective communication, judgment, and cross‑functional collaboration
Company
Kaztronix LLC
Kaztronix is a staffing and recruiting company that provides specialty consulting solutions.
201-500 employees
H1B Sponsorship
Kaztronix LLC 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
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Michael Kasmir
Managing Member & Co-Founder
Company data provided by crunchbase