Ecocareers · 1 month ago
Design Quality Engineer
Irvine, CA
Full-time
Onsite
Mid LevelEcocareers is a company focused on quality assurance in product development. They are seeking a Design Quality Engineer to develop quality assurance documentation, maintain quality system processes, and engage in risk management activities for new projects.
Staffing & Recruiting
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
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase