- Serve as a Quality Engineering representative on a cross-functional team (Manufacturing, R&D, Regulatory, etc.)
- Apply Quality Engineering knowledge to positively influence the product development process (PDP)
- Serve as quality reviewer and approver for design control changes.
- Create, review, and execute engineering tests and documentation including product specifications, design verification, validation, risk management, work instructions, etc.
- Ensure compliance with the quality system and may own corrective actions (CAPA).
- Execute the product development process to design, verify and transfer high quality products to commercial launch. Monitor and ensure product quality post launch.
- Perform other duties as assigned
- Bachelor's degree in Engineering or technical field or equivalent with a minimum 2 years of experience in a design quality engineering role in medical devices; Master's degree or equivalent with a minimum of 1 year of experience.
- Excellent, proven interpersonal, verbal, and written communication skills
- Experienced user of engineering tools, such as CAD, Statistics, Root Cause Investigations, and others to improve product quality.
- Detail oriented; deliver high quality work product consistently and on time.
- Ability to thrive in a fast-paced and dynamic work environment.
- Certification in Six Sigma Black Belt / ASQ certification preferred.
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Design Quality Engineer - Irvine, United States - Inari Medical
Description
Design Quality Engineer participates in all aspects of new product development in order to ensure the highest level of quality and their compliance to applicable regulations and standards.
Responsibilities
Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.