Sr. Design Quality Engineering

Sr. Design Quality Engineering Location: Irvine, California Job Type: C2C | Hybrid Pay Rate: $50/hr Industry: Manufacturing / Medical Devices End Date: 01-Jan-2026 Job Description We are seeking a Sr. Design Quality Engineering professional experienced in ensuring product quality compliance, supporting risk management activities, and leading verification and validation processes. The role requires strong collaboration with cross-functional teams, hands-on involvement in design control, and the ability to resolve quality issues through structured problem-solving and risk-based approaches. Responsibilities Ensure quality engineering activities meet regulatory and internal standards. Create and maintain product risk management documentation (Risk Plans, DFMEA, Risk Assessments, Risk Reports). Support development and execution of V&V plans, protocols, and reports. Perform Test Method Validation and process validation (PFMEA, IQ, OQ, PQ). Use statistical tools such as Minitab for data analysis. Oversee product testing to ensure compliance with applicable requirements. Apply Design Control principles to support sustaining engineering and product updates. Resolve quality issues and support design changes with cross-functional teams. Apply risk management techniques to identify and mitigate product risks. Use structured problem-solving methodologies to address product and process challenges. Prepare technical documentation, reports, and presentations for stakeholders. Required Qualifications Experience with quality engineering in manufacturing or medical device environments. Strong knowledge of design control, risk management, and process validation. Hands-on experience with DFMEA, PFMEA, V&V activities, and statistical tools (Minitab). Ability to support sustaining engineering and design updates. Strong analytical, communication, and problem-solving skills. Experience collaborating with engineering, manufacturing, and quality teams. J-18808-Ljbffr