Hiring: Quality Engineer - 257769 Company: Medix™ Location: Washington DC-Baltimore Area Job Posted Time: 2026-09-15 12:20:41 Target Skills & Keywords : Risk Management, Root Cause Analysis About the job Experience: •1-2 years of Quality Engineering experience •2 years of Quality Engineering experience Required Skills: •Develop, implement, and continuously improve quality policies, procedures, and systems in accordance with ISO 13485, applicable GMP/GDP requirements, and 21 CFR Part 820 •Lead and manage •CAPA activities from initiation through effectiveness verification •, ensuring timely and sustainable resolution of quality issues. •Using appropriate problem-solving methodologies and drive cross-functional corrective and preventive actions. •Develop, review, and execute validation strategies and protocols for equipment, processes, software, and test methods •Risk management, FMEA, SPC, and other quality engineering methodologies to identify and mitigate manufacturing and product risks. •Support new product development, design transfer, process development, and manufacturing transfer activities from a quality engineering perspective. Qualifications: •Bachelor's degree in Engineering, Science, or a related technical discipline •, or equivalent combination of education and experience. •, preferably within the medical device or other regulated manufacturing industry •CAPA activities from investigation through implementation and effectiveness checks •Solid functional working knowledge of ISO 13485, 21 CFR Part 820, GMP, and GDP requirements. •In-depth knowledge of quality systems, manufacturing processes, and quality engineering principles. •Strong analytical, organizational, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment. •Excellent written and verbal communication skills, with the ability to communicate effectively with technical teams, operators, management, and external auditors. •Demonstrated capacity to work independently while collaborating effectively across Engineering, Manufacturing, Operations, Regulatory, and Quality functions. •Demonstrated ability to influence others and drive projects to completion without relying solely on direct authority. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!