Senior Quality Assurance Specialist

5 days ago


County Roscommon, Ireland FRS Recruitment Full time

Company Overview

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FRS Recruitment is a leading contract manufacturer of medical devices serving global healthcare companies.

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About the Role

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As a Quality Engineer, you will play a key role in ensuring the highest quality standards are met across production processes.

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Key Responsibilities:

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  • Provide ongoing quality support to maximise production performance and product integrity.">
  • Lead investigations into quality issues, identify root causes, and implement corrective actions.">
  • Ensure compliance with ISO 13485, ISO 14971, and FDA QSR 21 CFR Part 820 standards.">
  • Develop and maintain quality management systems, inspection plans, and risk assessments.">
  • Perform internal and external audits, including customer and regulatory body inspections.">
  • Support new product introduction (NPI) with process validations and documentation.">
  • Oversee non-conforming materials, CAPA investigations, and customer complaints.">
  • Train and mentor junior engineers, promoting a culture of continuous improvement.">
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Requirements:

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  • Education: Level 8 Degree in Engineering.">
  • Experience: Minimum three years' experience in a Quality Engineering role, preferably in medical devices.">
  • Skills: Strong problem-solving and data analysis skills.">
  • Ability to work cross-functionally in a fast-paced manufacturing environment.">
  • Excellent communication and interpersonal skills.">
  • Proficiency in Microsoft Office, with knowledge of Minitab and Syspro being an advantage.">
  • Strong understanding of GMP, validation, and regulatory standards.">
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Benefits:

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  • Negotiable">
  • Healthcare Pension">


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