Title: Senior Quality Engineer (Design)
Location: Irvine, CA On-site
Duration: 6 months+
Visa: Any Visas(except h1b and CPT)
Interview: Phone/Zoom
Key Role Responsibilities:
• Focus on activities supporting design control, design verification/validation, FMEA/risk management, specification development, statistical reliability, critical to quality/process control, acceptance sampling, and inspection/test methodologies
• Partner with R&D in the design of safe and effective devices, partner with Manufacturing Engineering to develop critical manufacturing processes and provide technical quality support for pilot production of test or clinical devices.
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop, update, and maintain technical content of risk management files
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Partner with R&D on the development of methods for design verification testing. Manage the test method validation for design verification testing including protocol/report writing, identification and procurement of test samples and execution of testing.
• Other incidental duties assigned by Leadership
Education and Experience Requirements:
• Bachelor's Degree in Engineering or related field, plus minimum 4 years relative quality engineer experience required
• Master's Degree in Engineering or related field will offset 1 (one) year required experience.
• Experience in Design Assurance and Design Verification required
• Experience as a Quality Engineer in Medical Device or Biotechnology industry required.
• Some Supplier Quality experience a plus (not required)
• Working knowledge of 2D drafting and 3D modeling practices (Creo Parametric, Solidworks, AutoCAD)
• Working knowledge of developing inspection Methods using Keyence, Smartscope.
Additional Skills and Experiences:
• Support controlled environment qualifications, IQ/OQ/PQ executions
• Demonstrated understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering and Design Assurance
• Professional knowledge of and adherence to Quality systems
• Proficient level utilization of MS Office Suite (Outlook, Word, Excel, MS Project); CAD experience IS MUST
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Working knowledge and understanding of statistical techniques
• Strong problem-solving, organizational, analytical and critical thinking skills
• Ability to manage competing priorities in a fast paced environment
• Thrives in a collaborative team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control