Quality Director (ISO 13485)

Stevanato Group - Ontario, CA

Hiring: Quality Director (ISO 13485) Company: Stevanato Group Location: Ontario, CA Job Posted Time: 2026-09-16 14:03:55 Target Skills & Keywords : Microsoft Excel, R, Six Sigma About the job Experience: •At least 5 years of leading and implementing quality systems in a pharmaceutical or medical device environment •Manufacturing experience in injection molding plastics industry (or equivalent industry) is a plus. Required Skills: •Strong time management with priority setting skills Qualifications: •Expert knowledge and interpretation of ISO 13485, ISO 9000 standards, 21 CFR 820 and cGMP compliance. •Demonstrated capacity to lead, implement quality management systems as applicable to ISO and 21 CFR regulations. •Demonstrate understanding of industry standard validation tools and techniques. •Demonstrated ability of metrology and basic inspection tools, metrology and injection molding workmanship standards. •Demonstrated capacity to develop/conduct quality related training programs. •Effectively communicate in both verbal and written. •Excellent English communication skills (both written and verbal). •Fluency in Spanish a plus. •Understanding and use of metrology equipment. •Demonstrated capacity to read drawings and good understanding of geometric tolerancing. Compensation: •$140,000 - $190,000 / year 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!