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Regulatory Affairs Quality Manager

1 week ago

County Roscommon, Ireland FRS Recruitment Full time
Quality Engineer Job Description

We are seeking an experienced Quality Engineer to join our team. As a Quality Engineer, you will play a crucial role in ensuring our production processes meet the highest quality standards.

Responsibilities:

Key responsibilities include:

  • Providing ongoing quality support to maximise production performance and product integrity.
  • Leading investigations into quality issues, identifying root causes, and implementing corrective actions.
  • Ensuring compliance with regulatory standards, including ISO 13485, ISO 14971, and FDA QSR 21 CFR Part 820.
  • Developing and maintaining quality management systems, inspection plans, and risk assessments.
  • Performing internal and external audits, including customer and regulatory body inspections.
  • Supporting new product introductions (NPI) with process validations and documentation.
  • Overseeing non-conforming materials, CAPA investigations, and customer complaints.
  • Training and mentoring junior engineers, promoting a culture of continuous improvement.
Requirements:

To be successful in this role, you will need:

  • A Level 8 Degree in Engineering.
  • Minimum three years' experience in a Quality Engineering role, preferably in medical devices.
  • Strong problem-solving and data analysis skills.
  • Excellent communication and interpersonal skills.
  • Proficiency in Microsoft Office, with knowledge of Minitab and Syspro being an advantage.
  • A strong understanding of GMP, validation, and regulatory standards.