The Senior Complaints Quality Engineer will provide engineering support in post market surveillance, with a focus on complaint investigations, product evaluations, root cause and complaint trend analysis. The associate is responsible for planning and coordinating the daily complaint engineering activities and is accountable for managing the complaint engineers time efficiently and effectively to meet specific quality metrics related to complaints. The associate will advocate for the execution of initiatives & projects to enhance quality performance as part of Continuous Improvement.
• Promote a work environment of continuous improvement that supports Terumo’s Quality Policy, Quality System and Global Regulations. • Function as the senior engineering complaint investigator. Perform decontamination and testing of returned devices. Perform data analysis, additional testing, simulation testing, and root cause investigations and resolutions in support of a thorough complaint investigation related to product quality and patient safety. • Establish root cause failure analysis techniques, processes and test methods utilizing sound systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. • Document detailed product failure analyses in complaint records. • Coordinate and host regularly scheduled reviews of post-market data. • Participate in Quality Management Reviews as requested. • Act as a mentor for complaint engineers. • Responsible for timely and effective coordination and/or execution of assigned project activities. • Define process improvements and implement solutions to improve the efficiency of post-market activities. • Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures. • Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. • Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions. • Prepare responses to customers and field associates as necessary per process. • Support internal and 3rd party audits with post-market related requests. • Provide training and support for quality system processes and complaint engineering practices.
Knowledge, Skills and Abilities (KSAs)