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Quality Assurance Systems Specialist

2 months ago


Slough, Slough, United Kingdom Orion Electrotech Full time
Job Description

We are seeking a dedicated and detail-oriented Quality Systems Engineer to join our team at Orion Electrotech, and ensure our products meet the highest standards of quality and safety.

Key Responsibilities:
  • Quality Management System (QMS): Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and FDA regulations.
  • Regulatory Compliance: Ensure all processes adhere to applicable regulatory requirements, including FDA, ISO, and other relevant standards.
  • Audits: Prepare for and participate in internal and external audits, including those conducted by regulatory bodies and customers.
  • Document Control: Oversee document control processes, ensuring all quality-related documentation is accurate, up-to-date, and compliant with regulatory standards.
  • Risk Management: Conduct risk assessments and develop risk management strategies to mitigate potential quality issues.
Requirements:
  • Proven training and experience in auditing to the ISO13485 standard.
  • Experience with QMS software and document control systems.
  • Minimum of 2 years of experience in quality systems engineering.