Integer Holdings Corporation
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The Quality Systems Engineer II performs engineering tasks, utilizing advanced quality tools and concepts to meet internal and external customer expectations. Responsibilities include supporting regulatory inspections, monitoring manufacturing compliance, reviewing documentation adequacy, participating in continuous improvement projects, and managing non-conforming materials.
As a General Operator at Integer, you will be part of a culture that values customer success, innovation, collaboration, inclusion, candor, and integrity.
The Regulatory Affairs Specialist III will prepare national and international regulatory submissions, support product submissions, review regulatory change requests, and maintain regulatory databases. Responsibilities also include supporting project development, coordinating customer queries, participating in audits, and collaborating on quality improvement processes.
The NPI Operator at Integer supports NPI Tech Solutions engineers in building and testing products, ensuring quality, following SOPs, and maintaining a clean and safe work environment. Responsibilities include compliance with documentation processes, asset care on equipment, and involvement in Continuous Improvement projects.
The Principal Quality Engineer at Integer will focus on ensuring compliance with quality standards, lead audits, mentor engineers, and drive continuous improvement initiatives in manufacturing. The role supports customer interaction and develops tools for innovation in quality management, aiming to enhance operational performance and reduce costs.
The Site Quality Leader will oversee quality systems for guide wire production, ensuring compliance with various regulatory standards and managing a quality team. Responsibilities include developing quality objectives, supervising quality engineers and documentation control, supporting production goals, and acting as the site representative for regulatory compliance.
The Quality Engineer II will maintain and improve quality systems, ensuring production compliance with regulatory standards such as ISO 13485 and ISO 14000. Key responsibilities include trend analysis, process control monitoring, managing quality plans and risk documents, and participating in NCR meetings. The role requires collaboration across departments to uphold quality standards and support lean manufacturing initiatives.
This role involves utilizing general and advanced engineering methods to meet customer expectations in the medical device industry. Responsibilities include evaluating engineering techniques, ensuring compliance with quality and safety standards, leading projects, and analyzing processes for improvements.
The Planning Manager is responsible for managing material planning, production scheduling, demand forecasting, capacity planning, and inventory management for the Electrochem business. This role includes leading the sales and operations planning process, supervising production planning associates, implementing Kanban systems, and ensuring on-time delivery to customers while maintaining minimum inventory levels.