Quality Engineer

Quality Engineer Job description Job Summary: Supports all quality system and functions. Assists in establishing systems to support the facility to drive continuous improvements and minimize the costs of non-conformance. Plans, schedules, executes and communicates all items regarding quality issues, Deviations, OOS, validations and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards and cGMPs. Essential Duties and Responsibilities: Analyze data, process capabilities, customer concerns and expectations and any other leading or lagging indicators, which may be used to improve product and process knowledge. Interact with customers in order to understand and integrate those requirements into manufacturing and quality system requirements. Identify manufacturing and development constraints. Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence. Assists facility with quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques. Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods. Participates in FDA, CAPH and Customer quality system audits. Manage the CAPA process including the review and approval to open new CAPAs as well as approving CAPA plans, timelines and verification of effectiveness plans to assure timely completion within the established goal, inclusive of Change Control establishment and maintenance. Lead investigation and root cause analysis to internal deviations, non-conformance reports and OOS. Support validation of facilities and equipment and process. Approve engineering studies and other protocols as required. Oversee Calibration and pest control activities. Performs other duties, as assigned based on business needs. Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules. Exhibits regular, reliable, punctual and predictable attendance. Basic Qualifications: Bachelor’s in Science or Engineering or equivalent experience. 5 Years of experience Preferred Knowledge in Pharmaceutical Manufacturing of Aseptic Products. Skills and Abilities: Excellent writing skills pertaining to SOP, and Data report generation. Experience with Project Management Tools, Quality Risk Management, and Six Sigma problem solving tools. Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description. Able to comply with the company’s safety policy at all times. Able to comply with the company’s quality policy at all times. Working Requirements: Good communication and writing skills to interact with others in a positive and technical manner. Must be able to understand direction and adhere to established procedures.