Quality Engineer - Failure Investigations

Join our dynamic team at DEKA and be at the forefront of solving complex technical challenges! As our Quality Engineer focused on Failure Investigations, you'll be a key player in our collaborative environment, leading root cause investigations and driving product improvements through systematic analysis. Quality Engineering is a high-visibility role with a significant, direct impact on the success of the project and the safety of our products. As a key contributor to our team, the following skills are required:Technical Expertise: Strong ability to comprehend complex electromechanical systems and apply engineering principles to failure analysis. Solid engineering foundation with practical problem-solving skills. Investigative Mindset: Natural curiosity and systematic approach to uncovering root causes through data analysis, inductive and deductive reasoning, and structured problem-solving methodologies. Risk Management Acumen: Understanding of how failure modes relate to product risks and ability to translate investigation findings into risk file updates. Project Leadership: Skilled in managing investigation timelines, coordinating with multiple stakeholders, and driving investigations to closure with actionable outcomes. Collaboration: Effectively lead cross-functional investigation teams, facilitate discussions, and build consensus around root cause and corrective actions. Foster a supportive and productive investigation environment. Analytical Thinking: Ability to synthesize complex technical data, identify patterns, and draw sound conclusions from incomplete or ambiguous information. Effective Communication: Ability to present investigation findings clearly and persuasively to diverse audiences, from technicians to senior leadership, adapting technical depth appropriately. Self-Motivated: Able to independently manage multiple concurrent investigations, prioritize effectively, and maintain momentum without constant oversight. Technical Writing: Proficient in documenting investigation reports, root cause analyses, and technical summaries with clarity, precision, and appropriate detail. As a Quality Engineer, you will contribute in the following areas:Lead and support field return investigations from initiation through closure, ensuring thorough root cause analysis and appropriate corrective actionsParticipate actively in multidisciplinary investigation teams, bringing quality and regulatory perspective to technical discussionsAnalyze field return data, failure modes, and trends to identify systemic issues and improvement opportunitiesInterpret investigation results and translate findings into actionable recommendations for design, manufacturing, or process improvementsEnsure investigation findings are properly documented and integrated into the risk management file in accordance with ISO 14971:2019Evaluate failure modes against existing risk analyses (FMEAs, Risk Analysis) and identify when risk file updates are warrantedAttain and maintain comprehensive understanding of device design, manufacturing processes, and core technologies to support effective investigationUtilize structured problem-solving methodologies (e.g., 5 Whys, Ishikawa diagrams, Fault Tree Analysis) to systematically identify root causesReview and approve investigation reports to ensure accuracy, completeness, and regulatory complianceProvide guidance on QMS, FDA Part 820, and ISO 13485 compliance as it relates to investigations and corrective actionsCollaborate with design, manufacturing, and test teams to implement and verify corrective actionsContribute to continuous improvement initiatives based on investigation insightsRequired Training / Knowledge:BS/MS in Science or Engineering3-5 years' experience in quality engineering, failure analysis, or related role in a regulated environmentDemonstrated experience leading or supporting root cause investigationsStrong understanding of failure analysis methodologies and problem-solving toolsKnowledge of FDA's Quality System Regulation (21 CFR Part 820)Knowledge of ISO 13485 and related quality standardsExperience with Risk Management principles (ISO 14971)Experience with Corrective and Preventive Action (CAPA) processesStrong data analysis and interpretation skillsExcellent written and verbal communication skillsProficient in data analysis and documentation tools, including Excel, Word, Visio, and statistical analysis software. Nice to have:Experience with medical device field returns and complaint handlingKnowledge of ISO 10993 (biocompatibility) and other product testing standardsExperience with Design for Reliability (DFR) principlesFamiliarity with statistical analysis tools (Minitab, JMP, etc.)Experience with electromechanical device developmentSix Sigma or other formal problem-solving certification (Green Belt, Black Belt)Experience interfacing with regulatory bodies or participating in audits