Senior Quality Engineer (Manufacturing)

Katalyst CRO; Plano (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

Ein dynamisches Unternehmen sucht einen erfahrenen Senior Quality Engineer, der die Qualitätsinitiativen leitet und die Einhaltung von Standards in einer sich ständig weiterentwickelnden Fertigungsumgebung sicherstellt. In dieser Rolle sind Sie verantwortlich für die Implementierung und Überwachung von Qualitätsmanagementsystemen, die Durchführung interner Audits und die Leitung eines Teams von Qualitätsingenieuren. Sie bringen umfangreiche Kenntnisse in regulatorischer Compliance und kontinuierlicher Verbesserung mit. Wenn Sie ein proaktiver Problemlöser sind, der die Qualität in der Fertigung verbessern möchte, dann ist diese Position genau das Richtige für Sie.

Qualifications

• 5+ Jahre Erfahrung in der Qualitätsingenieurwesen, vorzugsweise in der Fertigung.
• Erfahrung mit ISO 9001:2015 und regulatorischen Standards.

Responsibilities

• Leitung und Pflege des ISO 9001:2015 Qualitätsmanagementsystems.
• Überwachung der statistischen Prozesskontrolle zur Verbesserung der Produktqualität.

Skills

Qualitätsmanagementsysteme

Statistische Prozesskontrolle (SPC)

Regulatorische Compliance

Fehler-Möglichkeits- und Einfluss-Analyse (FMEA)

Lean Manufacturing

Six Sigma

Teamführung

Analytische Fähigkeiten

Education

Bachelorabschluss in Ingenieurwesen

Fortgeschrittener Abschluss (Master)

Job description

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Position Summary

We are seeking a highly skilled and detail-oriented Senior Quality Engineer to lead quality initiatives and ensure compliance with applicable standards in a dynamic manufacturing environment.

This role requires a deep understanding of quality management systems, continuous improvement methodologies, and team leadership.

The ideal candidate is a proactive problem-solver with strong experience in regulatory compliance, statistical methods, and supplier quality management.

Responsibilities:

• Lead and maintain the organization's ISO 9001:2015 Quality Management System (QMS) to ensure consistent compliance and continuous improvement.
• Implement and oversee Statistical Process Control (SPC) across manufacturing operations to monitor and improve product quality.
• Supervise and mentor a team of quality engineers and technicians, providing guidance, training, and performance feedback.
• Manage the Corrective and Preventive Action (CAPA) process, including root cause analysis and implementation of effective solutions.
• Conduct and facilitate Failure Mode and Effects Analysis (FMEA) to identify and mitigate potential risks in design and process stages.
• Develop and maintain quality control plans, inspection criteria, and documentation in alignment with customer and regulatory requirements.
• Oversee supplier quality management, including audits, performance evaluations, and corrective action tracking.
• Perform internal audits to evaluate the effectiveness of the QMS and drive improvements.
• Ensure ongoing compliance with regulatory requirements relevant to manufacturing and industry standards.
• Champion Lean manufacturing principles and support cross-functional continuous improvement initiatives.

Requirements:

• Bachelor's degree in engineering or related field; advanced degree a plus.
• 5+ years of experience in quality engineering, preferably in a manufacturing environment.
• Proven experience with ISO 9001:2015 and regulatory standards.
• Strong knowledge of SPC, CAPA, FMEA, and quality planning methodologies.
• Familiarity with Lean and Six Sigma tools and techniques.
• Demonstrated leadership in managing teams and cross-functional projects.
• Excellent analytical, organizational, and communication skills.
• Certified Quality Engineer (CQE) or similar certification preferred.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Quality Assurance
• Industries: Pharmaceutical Manufacturing