GRIFOLS, S.A.
Automation Technician(m/w/x)
Vollzeitnur vor OrtBerufserfahren
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Managing ISO 9001 QMS for biopharma and aerospace manufacturing. 5-10+ years in regulated environments, audit leadership required. Hybrid work, 10% salary in shares after 1 year.
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Anforderungen
- Bachelor’s degree in Engineering, Quality, Science, Management, or related discipline
- Master’s degree preferred
- 5–10+ years managing quality systems in manufacturing, medical device, pharmaceutical, or regulated environment
- Experience leading audits, supplier quality activities, CAPA systems, and quality improvement programs
- ISO 9001 Lead Auditor certification preferred
- Additional certifications (ISO 13485, FSSC 22000, Six Sigma) advantageous
- Quality Management Systems (ISO 9001)
- Audit and Regulatory Compliance
- CAPA and Root Cause Analysis
- Supplier Quality Management
- Quality Metrics and Data Analysis
- Continuous Improvement / Lean / Six Sigma
- Leadership and Team Development
- Strong Communication and Cross-Functional Collaboration
- Excellent Organizational and Documentation Skills
- English and French proficiency required
- Hybrid working with occasional travel to customer sites
Aufgaben
- Lead and maintain the ISO 9001 Quality Management System
- Develop, update, and control quality procedures and documentation
- Monitor compliance with applicable standards and customer requirements
- Coordinate internal and external audits
- Support certification activities
- Oversee incoming, in-process, supplier, and final inspections
- Establish and maintain quality control processes and acceptance criteria
- Review quality performance metrics
- Drive corrective and preventive actions
- Investigate nonconformances and customer complaints using root cause analysis
- Support acceptance, calibration, and metrology programs
- Partner with global teams to improve quality performance
- Ensure effective implementation of quality requirements
- Verify compliance with established quality standards
- Lead and develop quality personnel and cross-functional teams
- Promote a culture of quality awareness and accountability
- Lead continuous improvement initiatives and quality system enhancements
- Communicate quality performance, risks, and opportunities to management
- Serve as the primary contact for regulatory agencies and certification bodies
- Ensure audit readiness and maintenance of an auditable QMS
- Support compliance with food safety and other applicable requirements
- Stop production when quality requirements are not followed
- Conduct internal audits
- Initiate and lead corrective actions
- Approve quality-related documentation and certifications
Berufserfahrung
5 - 10 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – fließend
Französisch – fließend
Tools & Technologien
ISO 9001ISO 13485FSSC 22000Six SigmaLean
Benefits
Flexibles Arbeiten
- Hybrid working
Sonstige Vorteile
- Occasional travel for FAT/SAT
Attraktive Vergütung
- 10% salary in shares after 1 year
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens ILC Dover erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei ILC DoverÜber das Unternehmen
IL
ManufacturingRossens FR
The company is a global leader in the design and manufacture of innovative solutions for the biopharmaceutical, pharmaceutical, medical device and aerospace markets.
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