Quality Systems Assistant

Cartago
Permanente
Tiempo completo

Hace 12 días

Job function summaryQuality Systems Assistant primary function is maintenance and review of the quality systems processes to ensure compliance and improvements to the system in collaboration with Quality Systems Engineer. Additionally to support document control and archiving process for the value streams in production, and general support across all value streams. And furthermore, being responsible for conducting stability studies for products during material changes.Major areas of accountability

Document control in the documentation system (overall support) as well as archiving the process of documentation for value streams in production
Supporting non-conformities related to documentation process
Supporting and training in good documentation practice (GDP), and ensuring that the knowledge is distributed to all employees (production and non-production) on site
Qualification of stability study chambers/rooms in accordance with local and global requirements
Creating and handling stability studies (protocol, reporting) and being one point of contact with global function
Participation and facilitation in Root Cause Analysis sessions
Creation of Certificates (of compliance/analysis) for finished good production, and ensuring these are distributed to the markets
Involved and supporting in external and internal audits
Analyses and maintains processes and procedures to ensure compliance, effectiveness, and improvements to the quality system (including updating relevant procedures)

Reponsible for:

Performing their job in compliance with the guidelines given
Drawing attention to the manager to any difficulties in understanding or following the guidelines
Drawing attention to inefficiency of the system
Take responsibility for those safety aspects identified for the given position
Support the positive EHS culture

Essential qualifications

High School Diploma Completed
Technical degree within Quality or Productivity
Minimum 1-3 years of experience within medical device manufacturing
A2 english level
Knowledge with work in Microsoft Office 365 (Word, Excel, PowerPoint)

Prefer qualifications

Analytical and problem-solving skills
English level A2+
Experience in medical industry

Required knowledge, skills & abilities

Ability to effectively interact with various internal and external customers/ vendors
Ability to read, analyze, interpret, and implement department procedures
Must work well independently and be adaptable/flexible with team members
Attention to detail and ability to follow up on previous work
Must lead by example and demonstrate professionalism
Must set and follow through with behavioral expectations
Must pass skill and knowledge onto other team members

Con unos ambiciosos planes de crecimiento, Coloplast desarrolla y comercializa productos y servicios que hacen la vida más fácil a aquellas personas con necesidades de cuidados sanitarios especiales. Tenemos más de 16 000 empleados y nuestros productos están disponibles en más de 143 países. Somos una de las empresas líderes de dispositivos médicos a nivel mundial. Constantemente buscamos nuevas formas de hacer crecer el negocio : exploramos, aprendemos y buscamos nuevas formas de hacer las cosas.Coloplast se compromete a ser una organización inclusiva, donde las diferencias son bienvenidas, las personas desarrollan su potencial y tienen un fuerte sentido de pertenencia debido a _ no a pesar de_ sus diferencias. Por ello animamos a todos los candidatos idóneos y cualificados a presentar su candidatura independientemente de su sexo, edad, raza, nacionalidad, etnia, orientación sexual, creencia religiosa o capacidad física.Visítanos en .Síguenos en . Síguenos a .59545
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Coloplast

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