This Job Vacancy has Expired!

Quality Assurance Engineer

Posted on Mar 4, 2020 by Real Staffing Group

Dublin, Ireland
IT
Immediate Start
Annual Salary
Full-Time

My client are a medical device start-up based in Dublin 1 who are looking to hire a Quality Assurance Engineer who will support the product development of a structural heart device through design development, verification, clinical trials, validation and regulatory approval.

This is a really exciting opportunity to join an exciting early stage company.

Responsibilities:

  • Working as a part of a cross-functional team to design and develop a novel transcatheter heart repair device in line with user needs
  • Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality.
  • Support product verification and validation, including risk management, bio-compatibility testing (ISO 10993), microbiological (disinfection) validation and clinical evaluation
  • Support development of test methods for product evaluation and validation, including validations.
  • Ensure quality in the product's design for durability, usability, reliability, functionality, marketability, and manufacturability
  • Mitigating risks associated with the design, use and manufacture of Medical devices.
  • Support implementation and maintenance of a robust and fully compliant quality system in accordance with ISO 13485, including risk management
  • Continuous improvement of the QMS to meet the requirements of all stakeholders
  • Ensure product quality requirements are met both internally and throughout the supply chain during product manufacturing.
  • Support quality related activities for device manufacturing ensuring controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
  • Ensuring adherence to all organisational and external regulatory requirements.
  • Preparation and maintenance of documentation in compliance with the appropriate regulatory requirements

Requirements:

  • Degree or masters degree in science or engineering, or related disciplines
  • Minimum of 3 years of related experience in medical device Quality or Design Assurance
  • Class III medical product development experience preferred
  • Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
  • Previous auditing experience preferred.
  • Experience of statistics and a good working knowledge of test method validation.
  • Experience of preparing technical documentation
  • Excellent communication, organisational and time management skills

If this sounds like a good fit for you, please apply directly below and I will reach out to you to provide further details.

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy

Reference: 855954156

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