Infosoft, Inc. · 6 hours ago
Quality Engineer II (Product Development)
Irvine, CA
Full-time
Onsite
Mid Level
$53/hr - $65.67/hr
3+ years expInfosoft, Inc. is a Global medical device Manufacturer, and they are seeking a Quality Engineer II to support product development and ensure compliance with quality systems. The role involves collaborating with cross-functional teams and executing quality engineering activities to address unmet clinical needs in medical innovations.
ConsultingDeliveryHuman ResourcesInformation Technology
Hiring Manager
Chandan Kumar (Jeet)
Responsibilities
Perform Quality Engineering activities related to product development and existing product support
Ensure NPD processes comply with the quality system and applicable regulatory standards
Update risk management and design control files. Maintain relevant quality documentation
Develop and execute test methods, validations, and qualification plans
Support design verification and facilitate process validation and commercialization activities related to multi-site transfer
Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing
Other duties assigned by Leadership
Qualification
Required
Bachelor's degree in engineering or a scientific field & 4+ years' experience -OR- Master's Degree or equivalent in Engineering or Scientific field & 3+ years' experience
Preferred
Proficient understanding of medical device operations and/or manufacturing processes. Medical Device experience strongly preferred
Relevant experience in product development, quality assurance, and/or related fields
Knowledge and understanding of Engineering and Quality principles, theories, and concepts
Understanding of ISO 13485
Experience developing, updating, and maintaining technical content of risk management files
Basic understanding of statistical techniques. Experience using statistical software (i.e., Minitab) is a plus
Experience in test method development, including validation and/or fixture development
Solid problem-solving, organizational, analytical, and critical thinking skills
Good documentation and communication (e.g., written and verbal) skills with keen attention to detail
Ability to build productive working relationships and interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
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