| Quality Engineer || El Paso, TX || at Remote, Remote, USA |
| Email: [email protected] |
| Greetings from Tanisha Systems!! Hope you are doing great today !! My name is Muskan & I am glad to write you an email for the below-mentioned Job that I have with one of our clients would appreciate it if you could let me know about your interest in pursuing it or if you know anyone who might be a good fit. Role: Quality Engineer Job Description : Responsibilities: Advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance, quality control and preventative activities. Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA. Will develop and characterize processes that are capable, scalable and produce high yield. Will support the design of robust inspection strategies including CQAs, CTQs and MSAs to enable process risk identification, process characterization, capability and robust process control. Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA). Ensure all Risk Management outputs comply with ISO14971 Provide manufacturing quality engineering support for the execution of quality assurance activities during design transfer phases of new product development. Support the required stages defined in the product and process design cycle ensuring compliance with the current design control and transfer regulations and policy. Develop Measurement System Analysis (MSA) strategy and approve executed MSAs. Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable. Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination. Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis. Influence processes towards validation versus manual verification, where possible. Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment. Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies and tooling & fixture development Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP). Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals. Eligibility: Bachelors degree in science, engineering, or manufacturing discipline Experience in ISO-13485 certified and cGMP organizations preferred. 10+ years experience to lead and drive the manufacturing PPAP with suppliers and collaborate with QE - NPI and ability to engage cross functional team on all aspects of plant operations. Working knowledge of FDA, cGMPs/QSR and ISO quality system requirements Thanks, and Regards, Muskan Shukla Sr.Technical Recruiter Desk: 212-729-6543 Ext 635 Tanisha Systems Inc. 99 Wood Ave South, Suite # 308, Iselin, NJ 08830 Email: [email protected] Muskan Shukla | LinkedIn -- Keywords: access management information technology New Jersey |
| [email protected] View all |
| Mon Nov 06 19:56:00 UTC 2023 |