Senior Quality Systems Professional

2 weeks ago

Athlone, County Westmeath, Ireland beBeeRegulation Full time €57,000 - €87,000

Quality Assurance Specialist

This is a fantastic opportunity to play a key role in maintaining and enhancing quality systems within a regulated environment. You will be at the forefront of ensuring compliance, driving continuous improvement, and supporting product development in a dynamic and collaborative setting.

Your Key Responsibilities:

  • Maintain and improve quality processes aligned with ISO 13485 and ISO 9001 standards.
  • Develop and revise Standard Operating Procedures (SOPs) and quality documentation.
  • Conduct internal audits to ensure adherence to regulatory requirements.
  • Actively participate in customer and regulatory inspections.
  • Support new product launches, including trials, sampling, and production runs.
  • Monitor vendor performance, issue non-conformance reports, and implement controls to protect product integrity.
  • Report on quality performance metrics and lead process improvement initiatives.
  • Investigate and resolve validation deviations, non-conformances, and Corrective Action Preventative Actions (CAPAs).
  • Assist in the creation and execution of validation protocols, including data analysis and test scripting.

Requirements:

  • Bachelor's degree in Science, Engineering, or a related field.
  • Minimum of 3 years experience as a Quality Engineer in an ISO 13485 regulated environment.
  • Certified Internal Auditor to ISO 13485.
  • Proven experience in equipment validation and statistical analysis.
  • Strong interpersonal skills, attention to detail, and a proactive problem-solving mindset.

What We Offer:

  • Be part of a team that values precision, collaboration, and continuous improvement.
  • Gain exposure to a wide range of quality assurance activities in a regulated industry.
  • Develop your career in a supportive environment with opportunities for growth and learning.

About Us:

We are a dynamic company dedicated to delivering high-quality products and services. Our team is passionate about continuous improvement and excellence.

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