Staff Quality Engineer

4 weeks ago

San Jose, United States bioMérieux SA Full time

Lead the effort to align all Operations activities are aligned to applicable Quality System requirements using risk management and meeting customer requirements Support the Operations team to verify the production controls are in place to ensure consistent quality products are produced and shipped. Lead or support changes to the manufacturing procedures, equipment and tools to enable improved workflow with statistically significant sampling strategies Lead the resolution of quality issues related to manufacturing or testing during manufacturing Implement data collection / tools that will detect problems before they arise (statistic process control) Contribute or review the documentation of quality systems and programs supporting operations: CAPA, nonconformances, equipment qualification, validation, change orders, deviations / waivers, etc. Prepare for and and support regulatory and agency inspections/audits (ISO/MDSAP/etc.), investigations, and inquiries regarding production control. Support corporate/internal production control audits. Participate in site CAPA activities, including investigation, effectiveness, and root cause analysis, etc. Coordinate implementation of corrective actions and preventive measures, as needed. Function as QA subject matter expert for cross-functional Operations team related practices: facilitate risk management activities, provide guidance for strategy and content of requirements for manufacturing processes and test methods. Provide guidance on statistical techniques to enable consistent workflow of products. Lead the effort to align all Operations activities are aligned to applicable Quality System requirements using risk management and meeting customer requirements Support the Operations team to verify the production controls are in place to ensure consistent quality products are produced and shipped. Lead or support changes to the manufacturing procedures, equipment and tools to enable improved workflow with statistically significant sampling strategies Lead the resolution of quality issues related to manufacturing or testing during manufacturing Implement data collection / tools that will detect problems before they arise (statistic process control) Contribute or review the documentation of quality systems and programs supporting operations: CAPA, nonconformances, equipment qualification, validation, change orders, deviations / waivers, etc. Prepare for and and support regulatory and agency inspections/audits (ISO/MDSAP/etc.), investigations, and inquiries regarding production control. Support corporate/internal production control audits. Participate in site CAPA activities, including investigation, effectiveness, and root cause analysis, etc. Coordinate implementation of corrective actions and preventive measures, as needed. Function as QA subject matter expert for cross-functional Operations team related practices: facilitate risk management activities, provide guidance for strategy and content of requirements for manufacturing processes and test methods. Provide guidance on statistical techniques to enable consistent workflow of products. Knowledge, Experience, and Skills

Requires a minimum of eight (8) years increasingly responsible experience in a related industry regulated by FDA and/or ISO. Requires demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes. Must possess expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, IVDR, QSR, MDSAP, etc.). Requires effective written and oral communication skills to interact across all levels of the organization. Must have advanced working knowledge of Microsoft Office Package (Word, Excel, etc.). One or more of the following certifications is strongly desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt. Masters Degree in relevant discipline is highly desired.

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