Quality Operations Engineer Responsibilities: + Support the overall effort of Quality Assurance, Product Development & Manufacturing, and IT to develop new products in collaboration with external clients and manage the support systems required in that effort + Facilitate root cause analysis as part of exception investigations and incorporate the results into investigation documentation + Write, review, and edit technical documentation (batch records, material specifications, validation documents, etc.) in collaboration with PD&M and IT personnel to support the development and qualification of commercial and clinical products + Work closely with IT to oversee and lead GxP-related IT efforts, as appropriate (computer system validation evaluations, eQMS oversight, data integrity, etc.) + Work collaboratively with engineers, project teams, and IT as needed to develop applicable work instructions, product specifications, and validation documents + Track document review and approval routings; accurately track the status of multiple projects simultaneously + Prepare and route documents for approval, ensuring compliance with Good Documentation Practices (GDP) and FDA requirements + Interface with multiple internal disciplines: manufacturing, IT, analytical, supply chain, etc. + Occasionally interface with external suppliers and customers + Assist in the execution of project plans to satisfy required actions, milestones, and deadlines + Provide training to other team members as needed. + Adhere to and ensure compliance with Quality System Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), GDP, and FDA requirements Requirements: + Working knowledge of regulated manufacturing environments + Experience conducting/facilitating root cause analysis using standardized tools + Extensive experience supporting quality-related IT systems + Ability to create a variety of manufacturing, engineering, and IT documents including production batch records, specifications, test plans, and validation protocols/reports + ASQ quality engineer certification preferred + Strong command of English language including editing and proofreading skills, spelling, grammar, and punctuation + Great attention to detail and the ability to communicate well across functions and organizational levels + Capable of organizing information into a clear and concise written form + Ability to multi-task and work in a deadline-driven environment + Ability to work independently as well as with a team + Excellent command of Microsoft Office Suite, especially Word and Excel + Bachelor's Degree in a technical discipline (preferred) or an equivalent combination of education and professional experience