Compunnel Inc. · 1 day ago
Senior Quality Engineer -- KAUDC5708841
Irvine, CA
Contract
Onsite
Mid, Senior Level
$60/hr - $64/hr
4+ years expCompunnel Inc. is seeking a Senior Quality Engineer to join their Quality Engineering team. The role involves working closely with R&D and Manufacturing teams to develop advanced tools and technologies, ensuring compliance with quality systems and regulatory standards while supporting product development and cleanroom build activities.
Information Technology & Services
Hiring Manager
Kasak Tyagi
Responsibilities
Perform Quality Engineering activities related to product development and ongoing cleanroom build support
Ensure New Product Development (NPD) processes comply with quality system and applicable regulatory standards
Update risk management and design control files; maintain relevant quality documentation
Develop and execute test method validations and qualification plans
Support design verification, process validation, and commercialization activities, including multi-site transfers
Collaborate cross-functionally with R&D, Manufacturing, Regulatory, Clinical, and Marketing teams
Perform other duties as assigned by leadership
Qualification
Required
Bachelor's degree in Engineering or a Scientific field with 4+ years of relevant experience
OR
Master's degree (or equivalent) in Engineering or a Scientific field with 3+ years of relevant experience
Preferred
Strong understanding of medical device operations and/or manufacturing processes (medical device experience strongly preferred)
Experience in product development, quality assurance, or related fields
Knowledge of engineering and quality principles, theories, and concepts
Understanding of ISO 13485
Experience developing, updating, and maintaining risk management files
Basic understanding of statistical techniques; experience with tools like Minitab is a plus
Experience in test method development, validation, and/or fixture development
Strong problem-solving, organizational, analytical, and critical thinking skills
Excellent written and verbal communication skills with attention to detail
Ability to build productive working relationships across all organizational levels
Ability to manage multiple priorities in a fast-paced environment
Company
Compunnel Inc.
Compunnel Inc. is where AI-native solutions meet human ingenuity, helping enterprises reimagine talent, technology, and growth.
5001-10000 employees
H1B Sponsorship
Compunnel 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 (2276)
2024 (1682)
2023 (1992)
2022 (2366)
2021 (2223)
2020 (2220)
Funding
Current Stage
Late StageLeadership Team
Andy Gaur
Founder, Chairman & CEO
Karthik Natarajan
Executive VP & CTO
Company data provided by crunchbase