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Quality Assurance Specialist

1 month ago

Mountain Ash, United Kingdom Stirling Q&R Full time

Job Title: Quality Assurance Specialist

Company Overview:

Stirling Q&R is a leading company in the medical device industry, dedicated to delivering innovative solutions that enhance patient care. As a Quality Assurance Specialist, you will play a crucial role in ensuring our products meet the highest quality standards and regulatory requirements.

Position Summary:

You will be responsible for designing, implementing, and maintaining quality assurance processes throughout the product lifecycle. This includes developing and implementing quality assurance protocols and standards, conducting risk assessments and failure mode effects analysis (FMEA), and performing root cause analysis on product defects and nonconformities.

Key Responsibilities:

  • 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.
  • Conduct internal audits and support external audits, ensuring compliance with ISO 13485 and other applicable standards.
  • 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.

Additional Information:

  • Location: Based in the UK, with potential for hybrid work arrangements.
  • Opportunity for professional development and growth within the company.

Requirements

Qualifications and Skills:

  • 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.
  • Strong analytical problem-solving skills and attention to detail.
  • Excellent communication skills and ability to work collaboratively with cross-functional teams.
  • Proficient in Microsoft Office Suite and quality management software.