Quality Engineer

PHILLIPS-MEDISIZE, LLC • New Richmond, WI • 4h ago

JOB REQUIREMENTS: Quality Engineer, Phillips-Medisize, LLC, New Richmond, WI: Lead quality assurance activities for New Product Introduction (NPI) projects to ensure compliance with regulatory requirements (FDA, GMP, ISO 13485, etc). Support customer and regulatory audits. Manage and oversee quality documentation, including specifications, validation reports, and product dossiers (such as work instructions, DHR batch records, technical reports, and quality agreements). Support collecting, compiling, and formatting of process indicators to identify opportunities for improvement of quality and business metrics. Manage ERP system activities such as corrective actions, document control, and calibration management. Generate Validation Plans, equipment qualifications, protocol/test cases, deviation, and summary report documentation. Use statistical data analysis for validating manufacturing processes and making data-based quality decisions. Facilitate root cause investigations and corrective actions for nonconformances identified. Lead risk management activities, including Process Failure Mode and Effects Analysis (PFMEA) and Control Plans. Collaborate with suppliers on quality requirements and audits to ensure component and material quality. Full-time employment, Monday Friday, 40 hours per week. MINIMUM REQUIREMENTS: Bachelor\'s degree in Industrial Engineering, Mechanical Engineering, Quality Management, Life Sciences, or a related field and two years of experience in process quality engineering. Must have two (2) years of experience in all of the following: Utilizing risk management tools including PFMEA and Control Plans in a medical device manufacturing environment; Conducting statistical analysis using at least one of the following: Process Capability, Measurement System Analysis (MSA), Hypothesis Testing, or Statistical Process Control; Utilizing Statistical Software such as Minitab; Utilizing root cause investigation tools using at least one of the following: Fishbone Diagram, 5 Whys, or D8; Resolving deviations with Corrective Actions or Preventative Actions; Working in a Quality Management System (QMS) that complies with FDA 21 CFR 820 or other related medical regulations; Working in a QMS that complies with ISO 13485 and 9001; Creating and managing paper or electronic Device History Records (DHR) in accordance to Device Master Records (DMR); and Training personnel on the usage and execution of DHR. Must have at least one (1) year of experience writing Validation and Qualification documentation. Telecommuting permitted up to 2 days per week. International travel required up to 10%. Domestic travel required up to 10%. To apply, send resume to mlxjobs@kochind.com. Please include Job Number 193569 in the subject line. ** OTHER EXPERIENCE AND QUALIFICATIONS: MINIMUM REQUIREMENTS: Bachelor\'s degree in Industrial Engineering, Mechanical Engineering, Quality Management, Life Sciences, or a related field and two years of experience in process quality engineering. Must have two (2) years of experience in all of the following: Utilizing risk management tools including PFMEA and Control Plans in a medical device manufacturing environment; Conducting statistical analysis using at least one of the following: Process Capability, Measurement System Analysis (MSA), Hypothesis Testing, or Statistical Process Control; Utilizing Statistical Software such as Minitab; Utilizing root cause investigation tools using at least one of the following: Fishbone Diagram, 5 Whys, or D8; Resolving deviations with Corrective Actions or Preventative Actions; Working in a Quality Management System (QMS) that complies with FDA 21 CFR 820 or other related medical regulations; Working in a QMS that complies with ISO 13485 and 9001; Creating and managing paper or electronic Device History Records (DHR) in accordance to Device Master Records (DMR); and Training personnel on the usage and execution of DHR. Must have at least one (1) year of experience writing Validation and Qualification documentation. Telecommuting permitted up to 2 days per week. International travel required up to 10%. Domestic travel required up to 10%. To apply, send resume to mlxjobs@kochind.com. Please include Job Number 193569 in the subject line. ** APPLICATION INSTRUCTIONS: E-Mail a Rsum: mlxjobs@kochind.com

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