What are the responsibilities and job description for the Quality Engineer position at Martech Medical Products?
Point MedicalLocation: Crown Point, INJob Type: HybridLocal candidates only need apply, must be within reasonable commuting distance as on-site work is required.Relocation Assistance and Sponsorship are NOT offered for this position.We’re Hiring: Quality Engineer (Medical Device Manufacturing)Join our team as a Quality Engineer and help ensure the safety, reliability, and compliance of life‑changing medical devices. In this fast‑paced manufacturing environment, you’ll drive continuous improvement, support validations, lead CAPA investigations, and help maintain a world‑class quality system aligned with FDA 21 CFR 820 and ISO 13485.What You’ll Do:Support and maintain compliant quality systemsLead CAPA and root cause investigationsSupport IQ/OQ/PQ validations and internal/external auditsDevelop inspection methods and program vision systems (Keyence, Starrett, ROI)Analyze quality data and support continuous improvement initiativesContribute to risk management, supplier quality, and documentation (DHR/DMR/DHF)What We’re Looking For:Experience in medical device or regulated manufacturingKnowledge of FDA 820, ISO 13485, ISO 14971Skills in statistical tools (Minitab/JMP); Six Sigma or ASQ certifications a plusStrong technical writing and ability to manage multiple prioritiesIf you’re a proactive problem-solver with a passion for quality and compliance, we’d love to talk!Apply today and help shape the future of safe, innovative medical devices.Powered by JazzHRo9rLF2D6hc
Salary : $68,300 - $88,200