Senior QA Engineer

Your responsibilities will include: Supporting and implementing new SOPs, WIs, and/or KSDs to improve and/or standardize Post Market processes Working independently across the organization Bachelor's degree, preferably in a scientific or technical discipline. Minimum of 4+ years of medical device industry experience Effective research and analytical skills. Competency of Microsoft Office Suite (i.e., Word, Xcel, PowerPoint, Visio, etc.), and Statistical Analysis tools (or equivalent). Working knowledge of FDA, ISO, MDD and the medical device industry quality Strong research, communication and presentation skills Effective written and oral communication, technical writing, and editing skills Travel approximately <5% of the time Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366. Project Management Skills and Ability to manage multiple small projects. CAPA experience. Ability to work independently with minimal supervision Agile/Scrum experience