Quality Assurance Specialist

Posted 12 Feb 2019

Scotland - all, Scotland - United Kingdom

Req Id 188032


A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. 

Your Role: As a Quality Assurance Specialist you will support the site with all the implementation of Quality Assurance aspects. Ensuring processes and procedures are in compliance with ISO9001; ISO13485; 21 CFR 600; IVDD 98/79/EC and other appropriate regulations and standards. You will coordinate CAPA management system, including review and approval of investigation plans, actions and effectiveness checks, provide guidance and expertise for investigation of failures, prepare quality reports, data and Key Performance Indicators for presentation to senior management as required and as an input to Management Reviews and support the site with internal and external audits

Who You Are:

  • Degree in Science (chemistry, biology, medical technology) or equivalent professional training.
  • Previous experience in an FDA regulated industry (drug manufacturing, medical device, biologics, or related industry)
  • Knowledge/experience in cGMP, FDA regulations, SOP development, as well as an understanding of Quality Assurance audit functions and Quality principles
  • Strong analytical and problem-solving skills.
  • Competent in the use IT technology, such as Microsoft Word, Excel and PowerPoint.
  • Good communication skills with the ability to collaborate and present at all levels and functions of the organisation.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at

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You have accessed https://www.emdgroup.com, but for users from your part of the world, we originally designed the following web presence https://www.merckgroup.com.

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