Quality Engineer - Failure Investigations

Overview

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.

• Lead and support field return investigations from initiation through closure, ensuring thorough root cause analysis and appropriate corrective actions
• Participate actively in multidisciplinary investigation teams
  , bringing quality and regulatory perspective to technical discussions
• Analyze field return data, failure modes, and trends to identify systemic issues and improvement opportunities
• Interpret investigation results and translate findings into actionable recommendations for design, manufacturing, or process improvements
• Ensure investigation findings are properly documented and integrated into the risk management file in accordance with ISO 14971:2019
• Evaluate failure modes against existing risk analyses (FMEAs, Risk Analysis) and identify when risk file updates are warranted
• Attain and maintain comprehensive understanding of device design, manufacturing processes, and core technologies to support effective investigation
• Utilize structured problem-solving methodologies (e.g., 5 Whys, Ishikawa diagrams, Fault Tree Analysis) to systematically identify root causes
• Review and approve investigation reports to ensure accuracy, completeness, and regulatory compliance
• Provide guidance on QMS, FDA Part 820, and ISO 13485 compliance as it relates to investigations and corrective actions
• Collaborate with design, manufacturing, and test teams to implement and verify corrective actions
• Contribute to continuous improvement initiatives based on investigation insights

• BS/MS in Science or Engineering
• 3-5 years' experience in quality engineering, failure analysis, or related role in a regulated environment
• Demonstrated experience leading or supporting root cause investigations
• Strong understanding of failure analysis methodologies and problem-solving tools
• Knowledge of FDA's Quality System Regulation (21 CFR Part 820)
• Knowledge of ISO 13485 and related quality standards
• Experience with Risk Management principles (ISO 14971)
• Experience with Corrective and Preventive Action (CAPA) processes
• Strong data analysis and interpretation skills
• Excellent written and verbal communication skills
• Proficient in data analysis and documentation tools, including Excel, Word, Visio, and statistical analysis software.

• Experience with medical device field returns and complaint handling
• Knowledge of ISO 10993 (biocompatibility) and other product testing standards
• Experience with Design for Reliability (DFR) principles
• Familiarity with statistical analysis tools (Minitab, JMP, etc.)
• Experience with electromechanical device development
• Six Sigma or other formal problem-solving certification (Green Belt, Black Belt)
• Experience interfacing with regulatory bodies or participating in audits