Job Description

DUTIES     This position will be in Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices. This includes, but is not limited to, an in-depth product failure analysis (root cause analysis), clinical case evaluation, manufacturing and IFU/Training material reviews, and risk assessments to determine if escalations are required for further action.   KEY RESPONSIBILITIES: Assist engineering in performing investigations, compiling and analyzing data as requested, and entering data and investigation results into the Quality Management System per engineering guidance. This includes data review and selecting the appropriate results/response for complaint evaluations. Data analysis may include review of device history records and reporting on potential issues that may contribute to complaints. Assist with complaint monitoring through trending analysis and triggers for assessment and potential actions. Activities include reviewing complaint data for potential trends/patterns, calculating rates and metrics, and escalating issues where appropriate.

SKILLS Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering Basic understanding of statistical techniques Previous experience working in laboratory environment (standard lab protocols/procedures - they may assist with collecting data within the lab) Solid problem-solving, organizational, analytical and critical thinking skills Strict attention to detail Good documentation, communication and interpersonal relationship skills Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment Must be able to work in a team environment, including the ability to manage project and associated multiple tasks and activities Good computer skills in MS Office Suite; Basic to intermediate Excel skill levels desired

EDUCATION AND EXPERIENCE:  Bachelor's Degree or equivalent in Engineering or Scientific field, 1 year of related experience in data analytics Required (internship okay) Previous Lab experience is preferred Med device industry experience is a plus but not a must have  

Company Description

MWIDM is a certified minority and women owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. With over a decade of experience, MWIDM provides Workforce Solutions to a broad range of business sectors including Systems Integration, Banking & Finance, Telecommunications, Life Sciences, Healthcare, Energy, Technology and Supply Chain