Key Quality Assurance Specialist

5 days ago


Dartford, Kent, United Kingdom DiaSorin Full time

Estimate salary: £40,000 - £60,000 per annum

Job Overview

DiaSorin is seeking a highly motivated Key Quality Assurance Specialist to join our team in Dartford, United Kingdom.

About the Role

This exciting opportunity involves managing and maintaining the Supplier Management program, including supplier approval, audits, re-evaluation, and non-conformances. You will also coordinate and participate in internal and external site audits, ensure the accuracy and relevance of quality documents, and provide support to the Quality Assurance Team with various activities.

Responsibilities:
  1. Supplier Management Program Management: Oversee the Supplier Management program, ensuring it aligns with company policies and regulatory requirements.
  2. Site Audits Coordination: Coordinate and monitor completion of change notifications received from suppliers and maintain incoming material technical specifications.
  3. Quality System Support: Provide support to the Quality Assurance department in aspects such as NC and CAPA, Change Management, Risk Management, Post Market programme, Audit, QS Documentation, and Training.
  4. Management Review Coordination: Coordinate management reviews and ensure critical aspects of the quality system are highlighted and addressed.
Requirements
  • A sound knowledge of ISO standards and 3-5 years of experience in an ISO quality-controlled environment in commercial healthcare product manufacture.
  • IVDD/IVDR knowledge is beneficial.
  • Excellent problem-solving techniques, data analysis skills, and basic quality knowledge.
  • Accountability, high motivation, and proactivity.
  • Ability to form effective working relationships, excellent attention to detail, and adaptability to changing priorities.

Please note that this role requires flexibility and adaptability to meet organizational needs.



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