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.