Medical Device Quality Assurance Specialist

6 days ago


Slough, Slough, United Kingdom Redshore Full time

Job Summary

Redshore is seeking a highly skilled Quality Systems Engineer to join its team in Slough. As a Quality Systems Engineer, you will be responsible for the management, development, implementation, and continual improvement of an efficient and effective Quality Management System (QMS).

Key Responsibilities

  • Plan and conduct internal quality audits (EN ISO 13485:2016) in accordance with the audit schedule and company procedures and work instructions, ensuring all applicable regulatory requirements are met.
  • Ensure follow-up activities are conducted, including verification of actions taken and reporting of verification results.
  • Identify, record, and investigate nonconformities/potential nonconformities in accordance with company procedures and work instructions.
  • Identify and implement process improvements in conjunction with Line Managers/Process Owners to ensure processes required for the QMS meet the requirements of relevant ISO standards and applicable regulatory requirements.

Requirements

  • Experience of working within a Medical environment with exposure to ISO 13485.
  • Degree-qualified in an engineering or medical subject.
  • Good systems experience with strong regulations knowledge.

Benefits

  • GBP 45,000 - GBP 52,000 - Basic Salary
  • Pension
  • Life Assurance
  • Medical Cover
  • Excellent Holidays
  • Training and Development


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