Product Quality Engineer (R-23067)
Varian Medical Systems Inc
Palo Alto, CA
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JOB DETAILS
LOCATION
Palo Alto, CA
POSTED
30+ days ago
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 and 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.
Minimum Requirements
: Bachelors 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 Masters 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. Any suitable combination of education, training, or experience is acceptable.
Special Requirements:
Must have experience and/or academic training with each of the following:
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About the Company
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