Quality Systems Manager

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €90,000 - €120,000

About the Role:

  • The Quality Systems Manager will oversee and maintain a quality management system that complies with regulatory requirements, such as ISO 13485:2016 and FDA regulations.
  • Manage document control processes to ensure consistent and compliant processing of documents.
  • Represent the quality function at team meetings, providing guidance and completing documentation reviews.
  • Participate in risk management to identify and mitigate potential risks.
  • Liaise with technical operations to support device manufacturing, ensuring high-quality product delivery.
  • Prepare quality system metrics for management review.
  • Address customer complaints, adhering to regulations and reporting requirements.
  • Implement and manage the CAPA system, addressing observations and root cause analysis.
  • Maintain computerised system validation, following documented procedures and regulations.
  • Ensure internal audits are completed on schedule, addressing non-conformances and recommendations.
  • Support supplier management, ensuring adherence to quality system requirements.
  • Prepare reports, documents, and other technical documents as required.
  • Drive continuous improvement of quality system processes.

About You:

  • Bachelor's degree in Science or Engineering is required.
  • A minimum of eight years' experience in quality engineering or regulatory roles is preferred, preferably in the medical device industry.
  • Excellent written, interpersonal communication, and presentation skills are essential.
  • You should be able to effectively present information to peers and deliver work required to advance company goals.
  • Strong communications skills, summarizing information from different sources and presenting it coherently are necessary.
  • Solid grasp of team dynamics and ability to participate in teams delivering outstanding results is required.
  • Accountability and ownership of decisions, actions, and failures are expected.
  • Prioritization and focus on critical objectives among numerous project tasks and activities are necessary.

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