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Quality Assurance Specialist

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.

 

Job Requisition ID:  188032
Location:  Scotland - all
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


Job Segment: Medical, CAPA, Medical Technology, QA, Healthcare, Quality, Management

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