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Quality Assurance Specialist

2 months ago

Leeds, Leeds, United Kingdom ALOIS Solutions Full time

Job Summary:

A Quality Assurance Specialist at ALOIS Solutions will play a critical role in ensuring the quality and compliance of our products and processes. This position will be responsible for partnering with cross-functional teams to introduce new products and processes, while also driving business improvements and ensuring regulatory compliance.

Key Responsibilities:

  • New Product/Process Introduction:
    • Collaborate with R&D and other stakeholders to ensure the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
    • Support new product introduction as part of design transfer.
    • Verify the completeness of validation documents and support process verification activities.
    • Assist in the development and validation of new test methods.
  • Business Improvements:
    • Support quality improvement initiatives that lead to continuous cost improvements.
    • Analyze the effectiveness of process improvement tools and programs, such as PDCA, Six Sigma, Kaizen, and Lean.
    • Conduct benchmarking to develop more effective methods for improving quality.
    • Support the development of quality engineering and compliance with the right skillsets for new product introductions and product life cycle management.
  • Compliance/Regulatory:
    • Analyze whether current products and processes comply with standards such as the QSRs, ISO 13485, etc.
  • Product Quality, Control & Disposition and Performance Standards:
    • Analyze the effectiveness of preventive and corrective actions, and review root cause investigations.
    • Accountability and ownership of quality metrics, including maintenance and review of leading and lagging indicators of quality.

Requirements:

  • Strong understanding of quality assurance principles and regulatory requirements.
  • Excellent communication and collaboration skills.
  • Ability to analyze complex data and drive process improvements.
  • Experience with quality improvement tools and programs.