Quality System Consultant / Auditor
Festo Microtechnology
Position OverviewFesto is seeking an experienced Quality System Consultant / Auditor to lead and support quality management initiatives across our operations located in North and South America. This role requires a strategic thinker with deep expertise in quality management systems, regulatory compliance, and continuous improvement methodologies. The candidate will serve as a trusted advisor to facility leadership by proactively identifying key challenges related to Quality compliance and translating them into actionable business improvements and solutions.Key ResponsibilitiesTo perform this job successfully, the candidate must be able to perform each essential duty satisfactorily.Consulting & AdvisoryServe as a reliable, candid sounding board for ideas, strategies, and decisions. Provide expert guidance on quality management system implementation and optimization managementAdvise leadership on quality strategy, risk management, and regulatory requirementsConsult and proactively provide training on quality challenges that arise (e.g. complex problem solving) in order to drive Quality KPI performance improvements.Facilitate root cause analysis and corrective/preventive action (CAPA) processesAudit & AssessmentPlan, conduct, and lead process and Quality Management System audits across multiple locationsEvaluate evidence-based compliance with ISO 9001, ISO 13485, and other relevant quality standardsAssess effectiveness of quality management systems and identify areas for improvementIdentify problematic areas of site and quality system operations and assist during and following the audit with assistance, suggestions, and recommendations to achieve the desired level of improvementDocument, analyze, and communicate audit results and strategic implications for FestoMonitor audit deviations and provide support, problem analysis, and escalation as necessaryPrepare, organize and support third party and customer auditsCompliance & StandardsMonitor compliance to global standards by validating the effectiveness of Festo's Quality Management System. Support certification and recertification processesMaintain knowledge of best practices in quality managementTraining & DevelopmentDevelop and deliver quality systems training programs for new auditors or other relevant team members Coach and mentor site leadership and relevant colleaguesBuild quality awareness and culture across the organizationContinue to develop and expand own personal skills, specific professional and technical expertise and technical auditing knowledgePerform other related duties as expected. Required QualificationsBachelor’s degree in engineering, Quality management, or related field5+ years of experience in quality management systems auditing and consultingAdvanced knowledge in the preparation, execution and documentation of process and system audits (ISO 19011, ISO 9001, VDA 6.3, ISO13485). Knowledge of additional standards is helpful.Strong knowledge of quality management standards and methodologies. Experience in translating standard requirements into understandable systems and solutions. Experience in working with international and intercultural production sites/organizationsAdvanced knowledge of process management, quality management systems, standards and certifications and methods (APQP, VDA RGA, control plan, inspection plan, PDCA, SPC, CIP ...), multi-project management and fundamentals of economicsKnowledge of problem solving (corrective and preventive action, 8D, 5 Why, A3 report, Ishikawa, ...) with a high level of attention to detailKnowledge in understanding specification sheets, customer requirements, technical drawings, measurements (e.g.: 3D, accuracy of measuring equipment (e.g.: VDA 5, MSA) and GPS (geometric product specifications)Experience in analyzing KPIs and trendsAdvanced training and facilitation skillsExcellent analytical, communication, and interpersonal skillsFluent in English; additional languages (Spanish, French, Portuguese and/or German) are an advantageValue-oriented, collaborative and solution-oriented way of working.Ability to maintain an overview in a multi-project environment and deliver sustainable, high-quality work results.Willingness to travel internationally (up to 40-50%)Preferred QualificationsMaster's degree or Six Sigma Black Belt certificationExperience with automation, pneumatics, or industrial technology sectorsCertified Quality Auditor (CQA) Change management experience and/or project management experience a plus.Benefits:Festo Corporation offers a robust benefits package, which is designed to help employees and their dependents stay healthy, feel secure and maintain a work/life balance. This is just one way we strive to provide employees with a rewarding workplace. As an effort to keep pace with healthcare trends, Festo Corporation is committed to providing a comprehensive benefits package to its employees which includes...Medical, Dental, Vision, Flexible Spending Programs, Short-term and Long-term disability, 401k, Pet Insurance, Paid Holidays, Paid time off, Educational assistance and many more.Festo is an equal opportunity employer. We believe that the best way to attract and retain a diverse workforce is to encourage a culture of inclusion within our organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
$57.4k - $99k
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$100k - $135k
Audit Manager Opportunity Location: Greater Cincinnati area, OH (hybrid) Compensation: $100,000 - $135,000, depending on experience About the Opportunity A well-established regional CPA and advisory firm in the Greater Cincinnati area is looking for an experienced...Flexible hours- ...Resilience is a biomanufacturing company seeking a Quality Assurance professional to support manufacturing processes within the Drug Product Process Execution Team and related areas. You will review batch records, manage documentation, and drive continuous improvement...
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$75k - $100k
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