Quality Engineer - 1st Shift Engineering - Columbus, NE at Geebo

Quality Engineer - 1st Shift

Company Name:
BD (Becton, Dickinson and Company)
Title: Quality Engineer - 1st Shift Location: Nebraska-Columbus West
Job Description :
Perform Quality Engineering work, which includes, but is not limited to, employee training, develop/change/monitor in-process inspections, work instructions, and procedures, corrective action responses, continuous improvement activities to support prefilled injectable syringe products, including validation activity (IQs, OQs, and PQs and/or APQP/PPAP of new and revised process/products). Provide Quality expertise (root cause analysis, statistical analysis, auditing, training, etc.) to research, process and development, manufacturing, trouble shooting, cost savings and the maintenance and improvement of the quality systems in manufacturing. Be an active team member or leader in the process of bringing new products to customers, improving current medical devices and/or automotive products and solving issues. Maintain quality systems through implementation, training, and auditing to assure a safe quality product to the end Quality Engineering (training, instructions, procedures, investigations and corrective actions, data analysis) and validation support (writing plans, protocols, and reports for IQs, OQs, and PQs and/or APQP/PPAP) in manufacturing. Ensure quality requirements per ISO13485, FDA 21CFR820 and/or ISO9001 and TS16949, and internal polices/procedures/work instructions are met as the Quality leader for project teams in manufacturing. Introduce new quality processes and materials in order to improve the performance of products. Identify quality issues (customer complaints, internal scrap, notifications, etc . . .) and investigate the root cause via AIR and CAPA and/or CAR/8D's process to suggest solutions in timely manner. Introduce Cost saving initiatives, projects, and quality improvement blitzes using six sigma and Kaizen methodologies. Provide training in Quality, regulatory compliance (ISO 13485 and FDA 21CFR820 and/or ISO9001 and TS16949), and new processes. Maintain and improve quality of products with frequent customer interaction.
Identify and improve the quality process inspection methods in order to increase the compliance of the products and relevant processes. Perform Quality validation (IQ, OQ, and PQ and/or APQP/PPAP) work. Provide expertise (root cause analysis, statistical analysis, auditing, training, etc.) to quality validation and customer support, research, process and development, manufacturing, trouble shooting and cost saving initiatives. Perform the job duties by working with different cross functional teams on multiple projects pertaining to products and processes of manufacturing.Assist in SureScrub and/or support the launch of different products and processes including machine installation implementation by ensuring all documentation is correct and available.Validation and ECO and/or ECN Engineering Change Number release for the line.Respond to customer complaints by providing investigation results of issue and root cause and corrective action, if applicable.Lead waste reduction projects by identifying sources of waste (scrap, downtime, rework, etc. . .) and securing team members to assist in developing and implementing actions to improve identified waste participate by providing analysis and data and attending required meetings for the various CTQ and/or FMEA teams.
EDUCATION AND EXPERIENCE REQUIREMENT:
Requires a Bachelor's degree in Engineering or Related Field and 6 months of experience in job offered or 6 months of experience in the Related Occupation.
RELATED OCCUPATION:
Quality Assurance Engineer or any other job title performing Quality Engineering work, which includes, but is not limited to, employee training, develop/change/monitor in-process inspections, work instructions, and procedures, corrective action responses, continuous improvement activities to support automotive products (APQP/PPAP process). Providing Quality expertise (root cause analysis, statistical analysis, auditing, training, etc.) to research, process and development, manufacturing, trouble shooting, cost savings and the maintenance and improvement of the quality systems in manufacturing. Be an active team member or leader in the process of bringing new products to customers, improving current automotive products and solving issues. Maintaining quality systems through implementation, training, and auditing to assure a safe quality product to the end Quality Engineering (training, instructions, procedures, investigations and corrective actions, data analysis) and validation support (writing plans, protocols, and reports for APQP/PPAP) in manufacturing. Ensuring quality requirements per ISO9001 and TS16949, and internal polices/procedures/work instructions are met as the Quality leader for project teams in manufacturing. Introducing new quality processes and materials in order to improve the performance of products. Identifying quality issues (customer complaints, internal scrap, notifications, etc . . .) and investigate the root cause via CAR/8D's process to suggest solutions in timely manner. Introducing Cost saving initiatives, projects, and quality improvement blitzes using six sigma and Kaizen methodologies.
Providing training in Quality, regulatory compliance (ISO9001 and TS16949), and new processes. Maintaining and improving quality of products with frequent customer interaction. Identifying and improving the quality process inspection methods in order to increase the compliance of the products and relevant processes. Perform Quality validation (APQP/PPAP) work. Providing expertise (root cause analysis, statistical analysis, auditing, training, etc.) to quality validation and customer support, research, process and development, manufacturing, trouble shooting and cost saving initiatives. Performing the job duties by working with different cross functional teams on multiple projects pertaining to products and processes of manufacturing.Supporting the launch of different products and processes including machine installation.Validation and ECN Engineering Change Number for automotive.Responding to customer complaints by providing investigation results of issue and root cause and corrective action, if applicable.Leading waste reduction projects by identifying sources of waste (scrap, downtime, rework, etc. . .) and securing team members to assist in developing and implementing actions to improve identified waste participate by providing analysis and data and attending required meetings for the various FMEA teams. __
Quality Engineering Quality Engineer - 1st Shift Nebraska-Columbus West QUA101UE Estimated Salary: $20 to $28 per hour based on qualifications.

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