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Quality Assurance Specialist

1 month ago

Mountain Ash, United Kingdom Stirling Q&R Full time

Job Title: Quality Engineer

At Stirling Q&R, we are seeking a Quality Engineer to ensure our medical devices meet the highest quality standards and regulatory requirements.

Position Summary:

As a Quality Engineer, you will be responsible for designing, implementing, and maintaining quality assurance processes throughout the product lifecycle.

  • Develop and implement quality assurance protocols and standards to ensure product compliance.
  • Conduct risk assessments and failure mode effects analysis (FMEA) for new and existing products.
  • Perform root cause analysis on product defects and nonconformities, driving corrective and preventive actions.
  • Participate in product design reviews and ensure quality considerations are incorporated.
  • Develop and manage quality metrics to track product quality and process performance.
  • Collaborate with manufacturing and engineering teams to optimize production processes for quality.
  • Provide training and support to staff on quality-related topics.
  • Document all quality activities and maintain accurate records.

Requirements:

  • Bachelor's degree in Engineering, Quality Assurance, or a related field.
  • 2-4 years of experience in quality engineering within the medical device or related industry.
  • Knowledge of quality management systems, ISO 13485, FDA regulations, and process validation.
  • Experience with statistical process control (SPC), Six Sigma methodologies, and quality improvement tools.
  • Proficient in Microsoft Office Suite and quality management software.