Quality Assurance Engineer

4 days ago

Cork, Cork, Ireland Barrington James Full time

Role Overview

The QA Engineer will be a key contributor to ensuring the quality and compliance of innovative medical devices and life sciences products. The role focuses on implementing robust Quality Control processes and ensuring adherence to ISO standards, particularly ISO 13485, to support the development and commercialization of cutting-edge healthcare solutions. The successful candidate will work closely with cross-functional teams to maintain high-quality standards in a dynamic, fast-paced environment.

Key Responsibilities

  • Develop and execute Quality Assurance and Quality Control processes to ensure compliance with regulatory standards for medical devices (Class I/II/III).
  • Conduct internal audits and support external audits to maintain ISO 13485 and other relevant ISO certifications.
  • Manage Corrective and Preventive Actions (CAPAs) and contribute to continuous improvement initiatives.
  • Collaborate with R&D, manufacturing, and regulatory teams to ensure quality standards are met throughout the product lifecycle.
  • Maintain and improve Quality Management Systems (QMS), with familiarity in tools like Greenlight Guru being a plus.
  • Support documentation, risk management, and validation activities in line with ISO standards and regulatory requirements.

Required Experience and Skills

  • Bachelor's degree in Engineering, Life Sciences, or a related field. Advanced degrees or certifications (e.g., CQE) are a plus.
  • 3+ years of experience in Quality Assurance or Quality Control within the medical device or life sciences industry.
  • Strong knowledge of ISO 13485, with additional experience in ISO 9001 or other relevant standards being advantageous.
  • Experience in working for a start-up company, or is looking to join a fast growing business.
  • Excellent problem-solving skills and attention to detail, with fluent English communication skills for cross-functional collaboration.

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