Quality Assurance Specialist

1 week ago

Athlone, County Westmeath, Ireland beBeeQuality Full time €60,000 - €80,000

Job Description

We are seeking a Quality Assurance Specialist to join our organization. As a key member of our quality team, you will be responsible for maintaining and enhancing quality systems within a regulated environment.

Main Responsibilities

  • Maintain and improve quality systems aligned with ISO 13485, ISO 9001, and applicable medical device regulations.
  • Develop and revise standard operating procedures (SOPs) and quality documentation.
  • Conduct internal audits to ISO 13485 standards.
  • Actively participate in customer and regulatory audits.
  • Support new product development, including trials, sampling, and production runs.
  • Monitor vendor performance, issue non-conformance reports (NCMRs), and implement controls to protect product integrity.
  • Report on quality performance metrics and lead change control initiatives.
  • Investigate and close validation deviations, non-conformances, and corrective actions plans (CAPAs).
  • Assist in the creation and execution of validation protocols (IQ/OQ/PQ), including data analysis and test scripting.

Required Skills and Qualifications

  • Bachelor's degree in Science, Engineering, or a related field.
  • Minimum of three 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.

Benefits

  • 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.

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