Martech Medical Products, Inc. · 2 weeks ago
Quality Engineer
Crown Point, IN
Full-time
Hybrid
Mid LevelMartech Medical Products, Inc. is seeking a Quality Engineer to ensure the safety, reliability, and compliance of life‑changing medical devices. In this role, you will drive continuous improvement, support validations, lead CAPA investigations, and help maintain a world-class quality system aligned with FDA and ISO standards.
MedicalMedical Device
No H1B
Responsibilities
Support and maintain compliant quality systems
Lead CAPA and root cause investigations
Support IQ/OQ/PQ validations and internal/external audits
Develop inspection methods and program vision systems (Keyence, Starrett, ROI)
Analyze quality data and support continuous improvement initiatives
Contribute to risk management, supplier quality, and documentation (DHR/DMR/DHF)
Qualification
Required
Experience in medical device or regulated manufacturing
Knowledge of FDA 820, ISO 13485, ISO 14971
Skills in statistical tools (Minitab/JMP)
Strong technical writing and ability to manage multiple priorities
Preferred
Six Sigma or ASQ certifications a plus
Company
Martech Medical Products, Inc.
Martech Medical Products is a medical device company that offers medical-grade extrusion and custom medical device.
Founded in 1978
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase