Senior Quality Engineer


Our client a high potential medical device start up is currently seeking a Senior Quality Engineer to join their team. The Senior Quality Engineer will report to the QA Manager and work across all stages of development, from prototyping, final manufacture, clinical investigation and commercialisation. The Senior Quality Engineer will support the QA Manager with maintaining the Quality Management System.


The Senior Quality Engineer should have a hands-on approach to projects with a motivated attitude and strong work ethic. An ability to work in a flexible and small entrepreneurial environment is essential.



Role/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.

• Bachelor’s degree in a relevant Engineering or Science field
• 4-5 Years’ experience in medical device industry or equivalent higher-level postgraduate study (masters or PhD)
• Project planning, communication and writing skills
• 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