Sr Product Quality Engineer - Onsite

Overview

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Varian Medical Systems, a Siemens Healthineers company is hiring for a Sr Product Quality Engineer. In this role you will be on-site to lead the efforts in designing, implementing, and maintaining quality assurance protocols and methods for processing materials into subassemblies or finished products. In this position, you will play an instrumental role in engaging with our local and global partners, driving various transformation initiatives and providing daily support to our manufacturing operations.

• Actively ensure 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.
• Provide 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.
• Provide engineering support to our local manufacturing and quality partners for the evaluation and disposition of nonconforming product and process related issues using a risk-based approach to resolve problems.
• Spend 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.
• Lead and participate in 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.
• Assist engineering in evaluating and defining requirements for automated manufacturing and testing integrated systems and processes.
• Experience with process and software validation and the ability to develop and write protocols, validation reports, engineering reports, etc. that support product development and manufacturing process changes in compliance with design controls.
• Active participation and decision making throughout the product life cycle (e.g., engineering changes, end-of-life, etc.) to assure that adequate quality assurance requirements are met, risks are thoroughly assessed and mitigated, and designs are adequately transferred into manufacturing with high process capability measured against critical to quality design output requirements.
• Execute 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.

• Bachelor’s degree in engineering (mechanical or electrical preferred) or…