Medical Device Quality Assurance Specialist

2 days ago

Cork, Cork, Ireland beBeeQuality Full time €60,000 - €80,000

Unlock a Career in Medical Device Quality Assurance

About the Role

The ideal candidate will be a key contributor to ensuring quality and compliance of innovative medical devices and life sciences products. The role focuses on implementing robust Quality Control processes, ensuring adherence to ISO standards, particularly ISO 13485. This will support the development and commercialization of cutting-edge healthcare solutions.

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.
Requirements
  • 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 looking to join a fast-growing business.
  • Excellent problem-solving skills and attention to detail, with fluent English communication skills for cross-functional collaboration.
Benefits
  • Seniority level: Mid-Senior level
  • Employment type: Full-time
  • Job function: Quality Assurance
  • Industries: Medical Equipment Manufacturing and Pharmaceutical Manufacturing
Work Environment

This is a dynamic, fast-paced environment where you will work closely with cross-functional teams to maintain high-quality standards.

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