Senior Medical Device Quality Assurance Specialist

7 days ago


Athlone, County Westmeath, Ireland beBeeRegulatory Full time €60,000 - €80,000
Job Overview

A seasoned quality assurance professional is sought to lead quality improvement initiatives, enhance processes, and ensure regulatory compliance in a dynamic medical device environment.

Main Responsibilities:
  • Process Optimization: Develop and implement process improvements to reduce costs, improve efficiency, and maintain regulatory standards.
  • Quality Systems Support: Assist in the development, implementation, and maintenance of quality management systems, including change controls, risk assessments, and process validations.
  • Data Analysis: Analyze data to identify trends and areas for improvement using statistical tools and techniques.
  • Documentation Management: Prepare, review, and maintain CAPAs, non-conformance reports, and supplier corrective actions.
  • Audit and Inspection Support: Conduct internal audits and support external inspections by regulatory bodies such as ISO and FDA.
Requirements:
  • At least 3 years' experience in a regulated environment, preferably in medical devices or FDA/ISO 13485 certified manufacturing.
  • Degree in Quality, Science, or Engineering.
  • Strong skills in MS Excel, Word, and PowerPoint.
  • Experience with FMEAs, root cause analysis, and statistical analysis.
  • Excellent attention to detail and problem-solving ability.
Benefits:

This role offers a unique opportunity to work in a fast-paced medical device industry, developing your skills and expertise while contributing to the success of our organization.

About the Role:

This is a 12-month contract position, providing an excellent chance to gain valuable experience and build your network in the industry.



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