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.