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Company: Varian Medical Systems, Inc.
Job Title: Product Quality Engineer
Job Site: 3100 Hansen Way, Palo Alto, California 94304
Minimum Requirements: Bachelor’s degree in industrial engineering, Industrial Technology, Biomedical Engineering, Mechanical Engineering, or related field (or foreign equivalent) and 2 years of related experience in the job offered or a related occupation or Master’s Degree in Industrial Engineering, Industrial Technology, Biomedical Engineering, Mechanical Engineering, or related field (or foreign equivalent) with no experience in the job offered or a related occupation.
Job Duties: Designing, generating, implementing and maintaining quality assurance and quality control protocols, standard operating procedures and methods for inspecting and processing materials into partially finished or finished products. Providing engineering support for designing and conducting research/technical projects and contributing to the identification of appropriate methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Assisting engineering in evaluating and defining requirements for automated manufacturing and testing integrated systems and processes. Providing engineering support to manufacturing and conducts the evaluation and disposition of nonconforming product and process related issues using a risk-based approach to resolve problems impacting production fulfillment. Providing all planning necessary and reviewing production schedules with cross-functional teams to ensure effective product acceptance based on the Device Master Records. Spending time on the manufacturing floor to determine process improvements, participating in investigations, root cause analyses, corrective action planning, implementation activities and interfacing with all cross functional departments to increase product quality using recognized Six Sigma and Lean methodologies. Ensuring compliance with internal and external safety, quality and regulatory standards requirements (e.g. Food and Drug Administration, International Organization for Standardization) by reviewing and approving product and quality system changes with Engineering and Manufacturing. Participating in Quality Review Boards, performing data analysis using appropriate statistical tools and techniques to identify trends, developing technical investigation plans, and recommending updates or changes to quality standards and procedures when necessary. Executing New Product Introduction/Design Transfer activities in characterizing manufacturing processes for parts/components in development to ensure smooth transition from Research & Development to manufacturing, including participation and leadership of the development of equipment and process validation requirements (Failure Modes and Effects Analysis, Installation Qualification, Operational Qualification, Performance Qualification), using appropriate statistical tools and techniques. May be involved in/lead activities related to the implementation and effectiveness of the equipment calibration program, such as: authoring, revising and maintaining equipment related procedures, work instructions and forms; creating, modifying and maintaining equipment calibration requirements; advising instrument owners/departments on calibration related issues; assisting cross-functional engineering groups in investigating equipment non-conformances and out of tolerance results; leading and/or contributing to system and process improvement projects; etc.
Special Requirements: Must have experience and/or academic training with each of the following:
1. Working knowledge on Quality System Requirements (QSR) such as GMP
2. Managing Validation project, protocols and Validation process procedures (IQ/OQ/PQ/TMV)
3. Quality Management System: CAPA (Corrective & Preventive action), NC (Non Conformance), Root cause analysis, SOP writing
4. Problem solving techniques, Lean Technics, Use of statistical tools
5. Advanced Statistical Process Control
Rate of Pay: $135,850/year
Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
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