Quality Engineer

Schott North America
paid time off, long term disability, tuition reimbursement
United States, Pennsylvania, Lebanon
30 Lebanon Valley Parkway (Show on map)
Jan 07, 2025
About us Your Contribution Lead process mapping and continuous improvement activities Perform site based risk assessments Support quality control plan analysis and improvements Coordinate, collect and analyze data for customers; troubleshoot and resolve customer issues; provide root cause analysis and corrective action Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions Ensure execution of global CAPA(s) Complete trend analysis for quality data Prepare customer audit finding responses Serve as internal and/or supplier auditor Support experimental and validation protocols for equipment, processes and materials, while designing protocols, performing tests and completing technical reports Develop and document best practice methods Train where applicable, and model cGMP Assist in customer audits and inspections Assure compliance with ISO certifications and Company policies/Code of Conduct Your Profile Bachelor's Degree in Mechanical, Materials or Industrial Engineering, or related field, required Minimum (5) years of experience within a Quality Engineer role Solid knowledge of ISO 9001, 13485 and 15378, along with cGMP and validation, preferred Experience in glass forming industry and/or pharmaceutical industry, preferred Sound computer knowledge and skills including MS Office and SAP Your Benefits Excellent healthcare benefits including medical, dental and vision Short and long term disability Tuition reimbursement Pet insurance Paid time off Other supplemental benefits available upon election Please feel free to contact us Your Profile Bachelor's Degree in Mechanical, Materials or Industrial Engineering, or related field, required Minimum (5) years of experience within a Quality Engineer role Solid knowledge of ISO 9001, 13485 and 15378, along with cGMP and validation, preferred Experience in glass forming industry and/or pharmaceutical industry, preferred Sound computer knowledge and skills including MS Office and SAP Your Contribution Lead process mapping and continuous improvement activities Perform site based risk assessments Support quality control plan analysis and improvements Coordinate, collect and analyze data for customers; troubleshoot and resolve customer issues; provide root cause analysis and corrective action Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions Ensure execution of global CAPA(s) Complete trend analysis for quality data Prepare customer audit finding responses Serve as internal and/or supplier auditor Support experimental and validation protocols for equipment, processes and materials, while designing protocols, performing tests and completing technical reports Develop and document best practice methods Train where applicable, and model cGMP Assist in customer audits and inspections Assure compliance with ISO certifications and Company policies/Code of Conduct