QA Engineer Job Specification

Opportunity

A medical device start-up looking to hire a QA Engineer who will support the product development of a cutting edge structural heart device through design development, verification, clinical trials, validation and regulatory approval. This position offers the opportunity to join an exciting early stage company. 

Role and responsibilities:

  • Ensuring adherence to all organisational and external regulatory requirements.
  • Preparation and maintenance of documentation in compliance with the appropriate regulatory requirements
  • Working as a part of a crossfunctional 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).

Requirements:

  • B.S. or masters degree in science or engineering, or related disciplines

  • Minimum of three (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.

  • Experience of statistics and a good working knowledge of test method validation.

  • Experience of preparing technical documentation

  • Excellent communication, organizational and time management skills

  • Availability to travel may be required

Availability to travel may be required