Senior Medical Device Quality Specialist

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time €60,000 - €80,000
Quality Assurance Associate

This role involves assisting in the maintenance of the Quality Management System (QMS) and managing internal processes to ensure product quality. The position requires a working knowledge of medical device regulatory requirements and standard practices in the medical device industry.

  • Maintaining the effectiveness of the QMS and making continuous improvements to it.
  • Managing day-to-day QA activities including frequent interface with contract manufacturers, QA consultants and testing contractors as well as handling multiple projects related to product and compliance enhancements.
  • Responsible for assisting in notified body audits and internal audits.
  • Maintain and coordinate quality system schedules, including: Supplier and internal audits; management review and documentation updates.
  • Support the wider team to ensure product manufacture and testing meets the requirements.
  • Building and maintaining strong relationships with suppliers, monitoring their performance, and conducting audits to ensure compliance with quality standards.
  • Investigating, analysing, and resolving any product quality problems, including root cause analysis and implementing corrective and preventive actions.
  • Ensuring that incoming materials meet the required specifications and working with the engineering team to address any quality concerns.
Key Requirements
  • Bachelor's degree in engineering or science. Quality certification in ISO 13485 a must.
  • A minimum of 4 years of experience in a medical device QA position(s) role within a medical device organisation.
  • Thorough understanding and knowledge of ISO 13485 and ISO 14971, EU MDR and 21 CFR Part 820.
  • Desirable to have lead auditor certification and/or Regulatory certifications.
  • Proven track record with the ability to successfully manage projects to deadlines.
  • Good Documentation Practice experience.
  • Report & Technical Writing experience.
  • Project Management experience.
  • Strong ability to manage critical projects as part of an interdisciplinary team.
  • Excellent problem solving and communication skills.
About This Opportunity

This is an exciting opportunity to join our team as a Quality Assurance Associate. You will play a key role in ensuring the quality of our products and services. If you are passionate about quality and have a strong background in medical devices, we would love to hear from you.

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