Senior Quality Engineer

Our client a medical device startup company is seeking a Senior Quality Engineer to join their team. Reporting to the Senior Quality Manager the Senior Quality Engineer will work across all stages of development, manufacture, and commercialisation. The candidate will support the Senior Quality Manager with maintaining the Quality Management System. The candidate will also work with R&D, manufacturing and regulatory teams to ensure the device meets user, regulatory and ISO 13485 requirements. Candidates 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:

• Provide quality support during in house manufacture and lot release
• Development of quality plans, programs and procedures for commercialisation
• 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
• Support during 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
• 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
• Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820) essential
• Cleanroom and sterilisation experience preferred
• Process validation experience preferred