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Medical Device Quality Assurance Specialist

3 weeks ago

Galway, Galway, Ireland Life Science Recruitment Full time

Company Overview

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  • A global leader in the medical device industry, expert in design, development, and manufacturing of complex devices and technologies.

Job Description

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  1. Lead project teams in establishing design history files and device master records, planning for clinical, pilot production, and scale-up.
  2. Ensure quality systems and regulations are utilized throughout product development.
  3. Evaluate material biocompatibility and sterilization methods during product design.
  4. Conduct risk assessments to determine design functionality.
  5. Manage CAPAs, change control, audits, product release, document control, and design control processes.
  6. Interact with customers and suppliers professionally, auditing and qualifying new suppliers as needed.
  7. Resolve technical issues and ensure work meets company's Quality Manual requirements.
  8. Continuously improve compliance and processes.
  9. Lead client programs, implementing new methodologies, materials, machines, and products.

Required Skills and Qualifications

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  • Bachelor's degree in Engineering or related field required.
  • 6+ years of medical device experience in design, development, or quality assurance.
  • Manage customer relationships and responses effectively.
  • Ability to interact with clients professionally.
  • Demonstrated ability to lead verification and validation activities.
  • Experience working with operations to develop manufacturing process instructions and operator training desired.

Benefits

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  • Hourly rate contract, 3 days a week (part-time).
  • Hybrid working arrangement.