Katalyst CRO
Overview
Join to apply for the
Supplier Quality Engineer
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Katalyst CRO Responsibilities
Process Validation and IQ-OQ-PQ: Experience in medical parts manufacturing with process validation expertise (approximately 8 to 10 years). Protocol Review & Compliance: Study and assess IQ, OQ, and PQ protocols and reports for regulatory and procedural compliance. Process Audits & Documentation: Conduct audits of manufacturing processes to identify documentation gaps and update QMS documents to reflect findings. Process Optimization: Design and execute DoE to optimize process parameters for CNC Machining and DCM; establish robust process parameters and operating windows. Validation Execution: Execute or re-execute validation protocols with data collection and generate IQ, OQ, PQ reports. Statistical Analysis: Run statistical reports to analyze process capability, variability, and performance trends. Change Management: Lead and document change management activities related to process improvements and equipment modifications. Continuous Monitoring: Monitor validated process parameters to ensure ongoing compliance and implement corrective actions as needed. Experience with QMS and ERP systems. Experience with IQ/OQ/PQ/TMV preferred. Collaborate with cross-functional teams and with Quality Engineering to provide manufacturing support. Provide manufacturing engineering support to projects, including change analysis, risk analysis, and manufacturing readiness. Experience in medical device manufacturing assembly lines; troubleshoot and resolve issues affecting safety, efficacy, quality, cost, or delivery of components and finished devices. Conduct qualification, verification, and validation activities to produce medical devices; contribute to new product development and product support (technology development, material testing, specifications, Six Sigma, process studies, and reports). Participate on cross-functional project teams; coordinate, manage, document project work and progress, and recommend revisions. Work with cross-functional teams on troubleshooting problems on the production floor. Qualifications
Bachelor's or master's degree in Mechanical Engineering, Biomedical Engineering, or related field. 5+ years of experience in medical device manufacturing with hands-on CNC Machining and DCM. Strong understanding of FDA, ISO 13485, and GMP requirements. Proficiency in statistical analysis tools (e.g., Minitab, JMP). Experience with QMS systems and documentation practices. Excellent analytical, problem-solving, and communication skills. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Supplier Quality Engineer jobs in
Skaneateles, NY .
#J-18808-Ljbffr
Join to apply for the
Supplier Quality Engineer
role at
Katalyst CRO Responsibilities
Process Validation and IQ-OQ-PQ: Experience in medical parts manufacturing with process validation expertise (approximately 8 to 10 years). Protocol Review & Compliance: Study and assess IQ, OQ, and PQ protocols and reports for regulatory and procedural compliance. Process Audits & Documentation: Conduct audits of manufacturing processes to identify documentation gaps and update QMS documents to reflect findings. Process Optimization: Design and execute DoE to optimize process parameters for CNC Machining and DCM; establish robust process parameters and operating windows. Validation Execution: Execute or re-execute validation protocols with data collection and generate IQ, OQ, PQ reports. Statistical Analysis: Run statistical reports to analyze process capability, variability, and performance trends. Change Management: Lead and document change management activities related to process improvements and equipment modifications. Continuous Monitoring: Monitor validated process parameters to ensure ongoing compliance and implement corrective actions as needed. Experience with QMS and ERP systems. Experience with IQ/OQ/PQ/TMV preferred. Collaborate with cross-functional teams and with Quality Engineering to provide manufacturing support. Provide manufacturing engineering support to projects, including change analysis, risk analysis, and manufacturing readiness. Experience in medical device manufacturing assembly lines; troubleshoot and resolve issues affecting safety, efficacy, quality, cost, or delivery of components and finished devices. Conduct qualification, verification, and validation activities to produce medical devices; contribute to new product development and product support (technology development, material testing, specifications, Six Sigma, process studies, and reports). Participate on cross-functional project teams; coordinate, manage, document project work and progress, and recommend revisions. Work with cross-functional teams on troubleshooting problems on the production floor. Qualifications
Bachelor's or master's degree in Mechanical Engineering, Biomedical Engineering, or related field. 5+ years of experience in medical device manufacturing with hands-on CNC Machining and DCM. Strong understanding of FDA, ISO 13485, and GMP requirements. Proficiency in statistical analysis tools (e.g., Minitab, JMP). Experience with QMS systems and documentation practices. Excellent analytical, problem-solving, and communication skills. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Supplier Quality Engineer jobs in
Skaneateles, NY .
#J-18808-Ljbffr