Katalyst CRO · 1 month ago
Design Quality Engineer
Irvine, CA
Contract
Onsite
Mid LevelKatalyst CRO is focused on providing quality solutions in the medical device industry, and they are seeking a Design Quality Engineer. The role involves developing quality assurance documentation, engaging in design and risk management activities, and ensuring compliance with regulatory requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop quality assurance documentation for new product development and regulatory submissions
Maintain and improve quality system processes by identifying and correcting deficiencies
Engage in design, development, manufacturing, and risk management activities for new projects
Participate in design reviews, identify product risks, and ensure effective mitigation strategies
Define and validate design verification and validation test requirements
Complete final design verification and validation reports with statistical and graphical support
Promote efficient testing practices and support manufacturing process development
Utilize statistical analysis and problem-solving techniques to establish product acceptance limits
Review and approve inspection plans, routers, and product drawings for new products
Support product design transfers to manufacturing facilities
Lead risk management activities, including developing risk management plans and conducting reviews
Qualification
Required
Experience with medical device product development lifecycle, including risk management and design/process verification and validation
Applied knowledge of advanced quality tools (FMEA, GD&T, Root Cause Analysis, Mistake Proofing)
Ability to read and interpret CAD drawings
Experience interacting with regulatory agencies (FDA, MoH, TUV)
Thorough knowledge of US and international medical device regulations
Strong understanding of quality concepts (CAPA, audits, statistics)
Excellent project management, communication, and problem-solving skills
Proficiency with analysis programs like MiniTab
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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