Quality Assistant

Our Quality Assistants ensures compliance with the quality system are responsible for training and education of operators within quality processes, as well as supports all functions in manufacturing in continuous improvement within quality related tasks.

Major areas of accountability

• Create and maintaining quality related documentation e.g. Device Master Record, Quality plan, Control plan, Quality record, local quality instructions (examples: visual control documents, List of defects)
• Handle non-conforming products incl. control of returned goods incl. handling and reporting in TrackWise and handling of lot status in E1
• Execute, support, coordinate testing and process validation activities
• Distribute product drawings and other controlled documents to production 
• Support implementation of new machines and Items transfers with quality related tasks
• Implementation, training and follow up in relation to continuously improvements, including participation in Root Cause Analysis sessions
• Perform additional ad hoc quality related tasks as appointed by Head of Quality
• 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

Essential qualifications

• Technical degree within Quality or Productivity, or min. 1-3 years of experience within medical device manufacturing
• Manager´s approval to apply. 
• At least 1 year working at Coloplast with no warnings over that time. 
• In case of being promoted, have at least 6 month in that position (does not apply for upgrades = level´s changes)
• In case of have travel for training purposes, have at least 6 months since the date you get back to CR. 

Preferred qualifications

• Knowledge with work in Microsoft Office 365 (Word, Excel, PowerPoint)
• Analytical and problem-solving skills

Required knowledge, skills & abilities

• Ability to effectively interact with various internal and external customers/ vendors
• Must work well independently and be adaptable/flexible with team members
• Attention to detail and ability to follow up on previous work
• Ability to read, analyze, interpret, and implement department procedures
• 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.

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