Werfen North America
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Quality Engineer III
role at
Werfen North America . Position Summary The position is responsible for ensuring that activities throughout the product lifecycle are compliant with procedures, standards, and regulations applicable to our products. The role involves developing, applying, and implementing methods, tools, and practices to achieve product quality goals in design, development, production, distribution, maintenance, and service. This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, and product development and production controls. Responsibilities Participates in the generation and review of quality documents throughout the product lifecycle. Advises and directs teams, in coordination with management, regarding compliance to procedures, standards, and regulations. Ensures product quality meets requirements and documentation is complete prior to approval. Participates on core teams supporting new product development or design changes. Advises teams on the implementation of Design Control and Product Realization requirements for design, production, and distribution of IL products. Provides guidance on tools and techniques for new product development and performance investigations. Contributes to defining product requirements, acceptance criteria, traceability, process monitoring, and failure analysis. Advises on the application of statistical methods and quality tools in evaluating design control, qualification, risk analysis, and product marketing. Provides guidance on software compliance, including cybersecurity and privacy standards. Reviews and approves change orders related to product performance, process changes, labeling, and marketing communications. Other duties as assigned. Secondary Functions Identifies compliance gaps and implements corrective actions. Supports internal and external audits. Participates in quality system improvement projects. Key Relationships Works closely with other functions to generate compliant documents, interpret quality procedures, standards, and regulations, and communicate quality requirements effectively. Qualifications Skills & Capabilities Knowledge of domestic and international quality/regulatory standards. Familiarity with quality management techniques (Lean, Six Sigma) and statistical methods. Understanding of IL products, technology, manufacturing processes, and their impact on customers and patients. Judgment to apply regulatory requirements appropriately. Risk-based decision-making skills. Minimum Knowledge & Experience Bachelor's degree or equivalent in engineering or science. At least 5 years of experience in medical devices, pharmaceuticals, diagnostics, or clinical labs, or 2 years with an advanced degree. Additional Skills/Knowledge Broad knowledge of engineering and science principles, including R&D, quality control, manufacturing, and design engineering. Problem-solving skills. Desirable: ASQ Quality Engineering Certification, LEAN/Six Sigma Certification. Language: English. Travel Requirements Approximately 10% of the time. Seniority level Mid-Senior level. Employment type Full-time. Job function Quality Assurance. Industries Medical Equipment Manufacturing.
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Quality Engineer III
role at
Werfen North America . Position Summary The position is responsible for ensuring that activities throughout the product lifecycle are compliant with procedures, standards, and regulations applicable to our products. The role involves developing, applying, and implementing methods, tools, and practices to achieve product quality goals in design, development, production, distribution, maintenance, and service. This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, and product development and production controls. Responsibilities Participates in the generation and review of quality documents throughout the product lifecycle. Advises and directs teams, in coordination with management, regarding compliance to procedures, standards, and regulations. Ensures product quality meets requirements and documentation is complete prior to approval. Participates on core teams supporting new product development or design changes. Advises teams on the implementation of Design Control and Product Realization requirements for design, production, and distribution of IL products. Provides guidance on tools and techniques for new product development and performance investigations. Contributes to defining product requirements, acceptance criteria, traceability, process monitoring, and failure analysis. Advises on the application of statistical methods and quality tools in evaluating design control, qualification, risk analysis, and product marketing. Provides guidance on software compliance, including cybersecurity and privacy standards. Reviews and approves change orders related to product performance, process changes, labeling, and marketing communications. Other duties as assigned. Secondary Functions Identifies compliance gaps and implements corrective actions. Supports internal and external audits. Participates in quality system improvement projects. Key Relationships Works closely with other functions to generate compliant documents, interpret quality procedures, standards, and regulations, and communicate quality requirements effectively. Qualifications Skills & Capabilities Knowledge of domestic and international quality/regulatory standards. Familiarity with quality management techniques (Lean, Six Sigma) and statistical methods. Understanding of IL products, technology, manufacturing processes, and their impact on customers and patients. Judgment to apply regulatory requirements appropriately. Risk-based decision-making skills. Minimum Knowledge & Experience Bachelor's degree or equivalent in engineering or science. At least 5 years of experience in medical devices, pharmaceuticals, diagnostics, or clinical labs, or 2 years with an advanced degree. Additional Skills/Knowledge Broad knowledge of engineering and science principles, including R&D, quality control, manufacturing, and design engineering. Problem-solving skills. Desirable: ASQ Quality Engineering Certification, LEAN/Six Sigma Certification. Language: English. Travel Requirements Approximately 10% of the time. Seniority level Mid-Senior level. Employment type Full-time. Job function Quality Assurance. Industries Medical Equipment Manufacturing.
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