Quality Assistant

This is a permanent position to work on site in administrative hours in our site located in Cartago, Zona Franca La Lima. 

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 in similar positions within medical device manufacturing

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

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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