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Design Quality Engineer

Job

REQ SOLUTIONS

Oceanside, CA (In Person)

Full-Time

Posted 2 days ago (Updated 8 hours ago) • Actively hiring

Expires 7/24/2026

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Job Description

Design Quality Engineer at
REQ SOLUTIONS
Design Quality Engineer at
REQ SOLUTIONS
in Oceanside, California Posted in about 4 hours ago.
Type:
full-time
Job Description:
Job Title:
Sr Design Quality Engineer Duration:
12+ Months (Possible extension)
Location:
Carlsbad, CA 92008
Onsite Role Responsibilities:
Support new product development and commercialized products that improve the delivery of care for patients around the world. Lead and apply advanced, systematic problem-solving methodologies to resolve complex product and process quality issues across the product lifecycle. Provide senior-level quality engineering leadership on cross-functional new product development teams, ensuring robust design inputs, verification and validation strategies and regulatory compliance. Drive the implementation and continuous improvement of risk management activities, including hazard analysis, fault tree analysis and FMEAs, ensuring alignment with ISO 14971 and internal standards. Develop and approve verification and validation protocols and reports, applying advanced statistical techniques and ensuring compliance with global regulatory requirements. Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs, ensuring inspection of readiness. Lead design change control activities, assessing product and process impacts while ensuring compliance and patient safety. Monitor field performance of new and established medical devices, analyze trends against risk assessments, and drive corrective and preventive actions as needed. Mentor junior engineers and contribute to the development of best practices that elevate team capability and performance.
Education/Experience:
Bachelor of Science degree in Engineering or a related technical field. Minimum of 7 years' experience in quality engineering or design assurance within the medical device industry. Demonstrated expertise in risk management, design controls and product verification and validation. Strong knowledge of global quality system regulations and standards, including ISO 13485 and
ISO 14971.
Ability to manage multiple priorities and navigate ambiguity in a fast-paced environment.
Preferred:
Degree in biomedical or mechanical engineering. Experience supporting structural heart, cardiovascular or implantable medical devices. Certification in quality engineering (e.g., CQE) or related credential. Demonstrated use of advanced quality tools and statistical methodologies