Infosoft, Inc. ยท 1 day ago
Quality Engineer (Design Control/Risk Management)
Irvine, CA
Contract
Onsite
Senior Level
$57/hr - $63.05/hr
5+ years expInfosoft, Inc. is seeking a Quality Engineer (Design Control/Risk Management) to collaborate with a cross-functional design team on cardiovascular devices and therapies. The role involves providing quality leadership throughout the product development cycle and ensuring compliance with internal and external requirements.
ConsultingDeliveryHuman ResourcesInformation Technology
Hiring Manager
Jack J
Responsibilities
Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management , Design Controls , Design Verification , Statistical Techniques, Test Method Development , Process Development, Quality Assurance, and Regulatory Compliance
Lead the Risk Management process for the project in compliance with the appropriate external standards and corporate policies, to ensure critical quality features are identified and addressed appropriately
Responsible for creating and maintaining risk management documentation, such as risk management worksheets, FMEAs, in alignment with ISO:14971
Provide integral technical input for the development of project plans, project timelines, and strategy to support premarket approval of products
Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities
Strong leadership and collaboration with other leaders in the project and across the organization
Mentor engineers in the understanding of quality systems and strategies within new product development
Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.)
Support resolution of manufacturing and compliance issues (i.e., CAPA, non-conformances, audit observations, etc.) utilizing problem-solving tools
Support Quality Engineering activities to improve customer satisfaction and the successful achievement of company quality objectives
Qualification
Required
Bachelor's Degree or equivalent in Engineering with 4 years of related industry experience OR Master's Degree in Engineering with 3 years of related industry experience
5-7 years of experience required
NPD experience as Quality/Design Assurance in Early Human Use, ISO 13485, ISO 14971
Experience in early medical device development as Design Assurance/Quality Engineer, results-driven, flexible, and critical thinking
In-depth knowledge of Design Control, Risk Management, and related standards, as applicable for medical devices
Knowledge of Quality Engineering and Six Sigma concepts, with the ability to apply to work products
Strong technical and analytical engineering skills. Able to understand drawings and device design at a practical level
Must be accurate in handling detailed information/data
Preferred
Experience in early human use of NPD strongly preferred
Experience in Design for Manufacturing (DFM) preferred
Certified Six Sigma Black belt / CQE preferred
Experience with electronic devices, data transmission/acquisition, a plus
Ability to read and interpret blueprints, technical drawings, schematics, and computer-generated reports
Previous experience with computer applications and software related to the engineering field, such as Computer-Aided Design (CAD)
Company
Infosoft, Inc.
Infosoft is an HR services company focused on recruiting talent and building teams throughout the US market.
201-500 employees
H1B Sponsorship
Infosoft, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (17)
2024 (37)
2023 (10)
2022 (14)
2021 (19)
2020 (23)
Funding
Current Stage
Growth StageCompany data provided by crunchbase