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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

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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

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