Hiring: Senior Specialist, Quality Systems Company: Orthofix Location: Carlsbad, CA Job Posted Time: 2026-09-10 15:08:19 Target Skills & Keywords : Agile, Microsoft Office, Product Lifecycle Management About the job Experience: •3-5 years’ experience in a QA or QC environment •5 years’ experience in a QA or QC environment •5+ years’ experience in a QA or QC environment Required Skills: •Supports company and department goals and objectives •Prepares, submits, and manages GUDID data to the FDA •Maintains the accuracy and completeness of device information within the GUDID, ensuring device labelers meet their UDI obligations •What skills and experience will you need? •The requirements listed below are representative of the education, knowledge, skill, and/or ability required for this position. •3-5 years’ experience in a QA or QC environment •Prior experience successfully implementing Quality Management Systems and electronic Quality System tools in regulated medical device and/or diagnostic companies •Expert knowledge of U.S. FDA Quality System Regulations (21 CFR 801, 803, 806, 807 and 820), ISO 13485, ISO 14971, European Union Medical Device Directive (MDD) and the Canadian Medical Device (CMDR) regulatory and standard requirements Qualifications: •High School Diploma or equivalent required •Prior experience successfully implementing electronic Quality System tools such as Agile, Reliance EtQ, Master Control, Oracle, Pilgrim, etc. Compensation: •$101,953 - $131,017 / year •N/A The anticipated salary for this position for an employee who is located in California is $101,953 to $131,017 per year, plus bonus, and benefits 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!