Zuidoost Nederland
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* VACATURE INGEVULD - Quality and Compliance Specialist Medical Devices Distribution Centre
Het bedrijf
Onze opdrachtgever is wereldwijd de grootste producent van medische apparatuur die zich richt op minimaal invasieve geneeskunde. Zij verbetert de praktijk van minimaal invasieve geneeskunde met een breed aanbod van innovatieve producten, technologieën en diensten. Dankzij deze innovatieve producten kunnen medisch specialisten het leven van patiënten verbeteren met alternatieven voor chirurgische ingrepen. Zij levert producten op het gebied van Pijnmanagement / Neuromodulatie, Interventie Cardiologie, Interventie Radiologie, Urologie / Gynaecologie, Neuro Radiologie, Hartritmemanagement / Elektrofysiologie, Broncoscopische ingegrepen en Gastro-enterologie.
De functie
Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and Global quality goals and priorities. Provide quality support within technical development concepts, new process development, operational, or system/services support.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Your responsibilities include:
• Establishes and promotes a work environment that supports the Quality Policy and Quality System
• Demonstrates a primary commitment to patient safety, product quality & customer service
• Implementing & maintaining compliance to the Global Quality System and improving the overall Quality System at the European Centre of Operations
• The implementation, co-ordination and continuous review of the Non-Conforming Event, CAPA & Compliance Review programs
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Pro-actively investigates, identifies and implements best in class Quality Engineering practices and implements/ manage improvement projects within the organization; (VIP, QMP, Star, Lean, 5S)
• Maintains controls, revises and updates associated documentation
• Management & Record Retention Systems in accordance with applicable Quality Systems Standards
• Acts as a Subject Matter Expert in Internal & External Audits
• Acts as a support or lead auditor in the execution of the site internal audit program
• Drives changes in procedures and standards to facilitate work efficiency and to maintain quality.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Your responsibilities include:
• Establishes and promotes a work environment that supports the Quality Policy and Quality System
• Demonstrates a primary commitment to patient safety, product quality & customer service
• Implementing & maintaining compliance to the Global Quality System and improving the overall Quality System at the European Centre of Operations
• The implementation, co-ordination and continuous review of the Non-Conforming Event, CAPA & Compliance Review programs
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Pro-actively investigates, identifies and implements best in class Quality Engineering practices and implements/ manage improvement projects within the organization; (VIP, QMP, Star, Lean, 5S)
• Maintains controls, revises and updates associated documentation
• Management & Record Retention Systems in accordance with applicable Quality Systems Standards
• Acts as a Subject Matter Expert in Internal & External Audits
• Acts as a support or lead auditor in the execution of the site internal audit program
• Drives changes in procedures and standards to facilitate work efficiency and to maintain quality.
Uw profiel
• 3-4 Years relevant experience in the Medical Device, Pharma or Food environment
• Green Belt certified ( is a plus) with process management experience
• Preferably has Auditing (Lead Auditor) and Quality Systems experience
• Familiar with quality tools and problem solving techniques
• Team player with strong work ethic and positive mentality
• Computer literate
• Good social and communication skills
• Strong analytical skills, "self starter" and eager to improve
• Good knowledge of the English language.
• Green Belt certified ( is a plus) with process management experience
• Preferably has Auditing (Lead Auditor) and Quality Systems experience
• Familiar with quality tools and problem solving techniques
• Team player with strong work ethic and positive mentality
• Computer literate
• Good social and communication skills
• Strong analytical skills, "self starter" and eager to improve
• Good knowledge of the English language.
Regio
Gelderland, Noord-Brabant, Limburg
Contactpersoon
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