Principal Product Complaint Analyst

Your responsibilities will include: Supporting and implementing new Standard Operating Procedures and Work Instructions to improve and/or standardize complaint and regulatory reporting processes Applying systems-thinking of a complex quality system to streamline and identify areas for improvement and identify areas of risk and provide and manage plans for improvement Working independently across the organization Bachelor's degree, preferably in a scientific, engineering, or technical discipline Minimum of 8+ years of medical device industry experience Demonstrated ability to understand, shift and contribute to changing priorities Competency of Microsoft Office Suite (i.e., Word, Xcel, PowerPoint, Visio, etc.), Working knowledge and practical implementation of FDA, ISO, MDR regulations within the medical device industry Demonstrated proficiency in project management Travel approximately <5% of the time Non-conformance and Corrective Action Preventative Action (CAPA) experience Strong research, communication and presentation skills Effective written and oral communication, technical writing, and editing skills Ability to work independently with minimal direction or supervision SAS, Snowflake or similar querying/analytic software experience