Senior Quality Engineer with medical devices experience required for key role with growing medical devices scale up in Dublin or Galway or remote. Reporting to the QA Manager, you will work across all stages of development, from prototyping, final manufacture, clinical investigation and commercialisation. You will also support the QA Manager with maintaining the Quality Management System; work with R&D, clinical and regulatory teams to ensure the device meets user, regulatory and ISO 13485 requirements.
Requirements:
- Bachelor’s Degree in a relevant Engineering or Science field
- 4-5 Years’ experience in medical device industry
- Sound understanding of engineering fundamentals
- Medical device materials knowledge
- Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820) essential
- Hands-on approach to projects
- Project planning, communication and writing skills
- A motivated attitude and strong work ethic
- An ability to work in a flexible and small entrepreneurial environment is essential
Key Responsibilities:
- Development of quality plans, programs and procedures, through all aspects of the product development process
- Ensure all work is carried out in compliance with Quality, Regulatory and company policies and systems
- Ensure that performance and product quality conforms to company, customer and regulatory requirements
- Review, analyse and report on quality discrepancies related to product design and manufacture
- Liaise and support OEM contractors/vendors during the manufacture of components and the assembly of devices for the purposes of design verification testing and clinical evaluation
- Provide quality input and support for product development teams
- Support the QA Manager in regulatory agency audits including FDA and Notified Body and aid in the preparation of non-conformity responses, as necessary
emer@emtechrecruitment.ie
