Senior Quality Engineer – Medical Devices

Senior Quality Engineer – Medical Devices

Immediate need for a talented Senior Quality Engineer – Medical Devices. This is a 06+months contract opportunity with long-term potential and is located in Los Angeles, CA (Hybrid).

Key Responsibilities:

• Provide Quality Engineering support for medical device products within a post-market and sustaining engineering environment.
• Lead and support non-conformance investigations, including technical assessment, root cause analysis, and disposition activities.
• Support CAPA investigations and corrective/preventive actions, ensuring appropriate documentation and timely resolution.
• Perform and support risk management activities, including evaluation and maintenance of product and process risk documentation.
• Analyze product and process quality data to identify trends, risks, and opportunities for improvement.
• Partner with Manufacturing and Operations Quality teams to investigate and resolve product and process quality issues.
• Collaborate with R&D, Engineering, Regulatory, Manufacturing, and other cross-functional teams to develop effective and compliant solutions.
• Provide quality engineering guidance to engineering and project teams throughout product lifecycle and post-market activities.
• Support quality activities associated with product launches, sustaining engineering, and ongoing product improvements.
• Prepare, review, and maintain accurate quality system documentation and technical records.
• Apply engineering judgment and structured problem-solving techniques to address complex quality issues.
• Ensure investigations and quality activities are completed in accordance with applicable quality systems, procedures, and regulatory requirements.
• Manage multiple investigations, projects, and competing priorities while maintaining a high level of quality and attention to detail.
• Support the quality organization in maintaining patient safety, product compliance, product performance, and continuity of therapy.

Key Requirements and Technology

Experience:

• Bachelor's degree in Engineering or a closely related technical discipline.
• 4–10 years of experience in Quality Engineering or a closely related quality function.
• Experience working in a regulated industry, preferably medical devices.
• Strong experience with one or more of the following:
• Non-conformance / NCR investigations
• CAPA
• Root Cause Analysis
• Risk Management
• Corrective and Preventive Actions
• Quality Systems
• Product and Process Quality
• Strong analytical and problem-solving capabilities.
• Excellent written and verbal communication skills.
• Demonstrated ability to work effectively with cross-functional engineering and business teams.
• Ability to independently manage multiple priorities and deliver high-quality work in a fast-paced environment.
• Experience in the medical device industry.
• Experience with post-market quality engineering or sustaining quality.
• Experience supporting diabetes, wearable, infusion, pump, monitoring, or connected medical devices.
• Knowledge of FDA regulations and medical device quality systems.
• Familiarity with ISO 13485 and risk management principles.
• Experience with structured root-cause methodologies and problem-solving tools.
• Experience working with Manufacturing, R&D, Regulatory, and Operations Quality organizations.
• Experience supporting product launches or sustaining engineering programs.