Medline
Quality Engineer - Urology Post Market Surveillance
Medline, Chicago, Illinois, United States, 60290
Job Summary
Under broad supervision, responsible for independently setting basic quality standards for both in-process and finished products, leading efforts to develop testing, sampling, and training methods. Evaluate production processes, recommend improvements, qualify and manage vendors, and generate and maintain DMRs, product specifications, design control files, and CE technical files.
Job Description MAJOR RESPONSIBILITIES: Manage the development and implementation of methods and procedures for process control, validation, improvement, testing, and inspection to ensure product quality. Design experiments to identify sources of variation, applying statistical process control (SPC) methods for data analysis and process evaluation. Conduct experimental product testing and analysis, generate reports, analyze defects, and lead corrective actions, using probability and statistical quality control concepts. Collaborate with suppliers on quality issues, implement corrective actions (CAPA, SCAR), and lead supplier qualification processes. Provide quality expertise in product development, design control, risk management, and CE technical files. Develop product documentation (e.g., Device Master Records) in compliance with regulations, and support regulatory submissions like 510(k) applications. Coordinate product testing with internal and external laboratories. Ensure compliance with applicable domestic and international regulations, and perform quality reviews of design and vendor documentation. Lead investigations of non-conformances and out-of-specification results, developing effective CAPA strategies. Education: Bachelor’s degree in Engineering, Science, Math, or related technical field. Work Experience: Minimum 2 years in Quality or Engineering roles. Knowledge / Skills / Abilities: Ability to work independently, escalate issues when necessary, and accomplish goals with minimal supervision. Strong time management skills to prioritize and track multiple projects. Problem-solving skills using systematic or mathematical approaches. Proficiency in MS Office Suite, especially intermediate Excel skills (conditional formatting, formulas, charts). Knowledge of quality assurance standards (e.g., 21 CFR 820, ISO 13485). Willingness to travel up to 15%. PREFERRED JOB REQUIREMENTS: At least 2 years of experience in Medical Devices, Drugs, or related fields. Medline offers a competitive benefits package, ongoing training, and growth opportunities. The salary range is $79,560 - $115,440 annually, commensurate with experience and location. Benefits include health insurance, life and disability coverage, 401(k), paid time off, and more. We value diversity and are an equal opportunity employer.
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Job Description MAJOR RESPONSIBILITIES: Manage the development and implementation of methods and procedures for process control, validation, improvement, testing, and inspection to ensure product quality. Design experiments to identify sources of variation, applying statistical process control (SPC) methods for data analysis and process evaluation. Conduct experimental product testing and analysis, generate reports, analyze defects, and lead corrective actions, using probability and statistical quality control concepts. Collaborate with suppliers on quality issues, implement corrective actions (CAPA, SCAR), and lead supplier qualification processes. Provide quality expertise in product development, design control, risk management, and CE technical files. Develop product documentation (e.g., Device Master Records) in compliance with regulations, and support regulatory submissions like 510(k) applications. Coordinate product testing with internal and external laboratories. Ensure compliance with applicable domestic and international regulations, and perform quality reviews of design and vendor documentation. Lead investigations of non-conformances and out-of-specification results, developing effective CAPA strategies. Education: Bachelor’s degree in Engineering, Science, Math, or related technical field. Work Experience: Minimum 2 years in Quality or Engineering roles. Knowledge / Skills / Abilities: Ability to work independently, escalate issues when necessary, and accomplish goals with minimal supervision. Strong time management skills to prioritize and track multiple projects. Problem-solving skills using systematic or mathematical approaches. Proficiency in MS Office Suite, especially intermediate Excel skills (conditional formatting, formulas, charts). Knowledge of quality assurance standards (e.g., 21 CFR 820, ISO 13485). Willingness to travel up to 15%. PREFERRED JOB REQUIREMENTS: At least 2 years of experience in Medical Devices, Drugs, or related fields. Medline offers a competitive benefits package, ongoing training, and growth opportunities. The salary range is $79,560 - $115,440 annually, commensurate with experience and location. Benefits include health insurance, life and disability coverage, 401(k), paid time off, and more. We value diversity and are an equal opportunity employer.
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