Quality Engineer

Martech Medical Products • Crown Point, IN

5d • Hybrid

About The Position

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.

Requirements

• 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

Nice To Haves

• Six Sigma or ASQ certifications a plus

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed