Quality Engineer II

STERIS - Conroe, TX

Hiring: Quality Engineer II Company: STERIS Location: Conroe, TX Job Posted Time: 2026-09-10 14:38:32 Employment Type: On-site Target Skills & Keywords : SAP, Visio About the job Experience: •3 years of related experience (Manufacturing/Quality Engineering and/or Quality Systems), required. •3 years of experience working in an ISO certified environment. Required Skills: •IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable standards. •This position requires working onsite in our Conroe, TX location between the hours of 7:30am to 4:00pm or 8am to 5pm. •Participate in cross-functional new product development teams with focus on product/ service quality and Quality System compliance. •Develop and implement statistically valid sampling plans, design experiments, capability studies, SPC and trend analysis. •Initiate and/or participate in process and product corrective actions and problem-solving activities. •Update/establish documented work instructions as needed. •Review collected data to perform statistical analysis and recommend process/product changes to improve quality. •Monitor and report on performance metrics. Qualifications: •ASQ, QSR Certification or familiarity with QSR/GMP regulations preferred. •Knowledge of medical device industry standards ISO 13485 and FDA 21 CFR Part 820/211 preferred. •QMS software (such as TrackWise or other QMS software system), SAP or Oracle experience, preferred. •We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future. Compensation: •$90,000 - $105,000 / year •Competitive benefits and rewards package •Extensive Paid Time Off and added Holidays 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!