Our client a high potential start up is looking to hire a Quality Manager who will lead the Quality activities to bring a cutting edge through design development, verification, clinical trials, validation and regulatory approval. This role will provide Quality leadership to meet objectives in the development, implementation and maintenance of a robust and fully compliant Quality System. This position offers the opportunity to join the management team in an exciting early stage company.


Role/Responsibilities

• Development, 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, ensuring processes are lean, compliant, user-friendly and are well understood throughout the organisation.
• Manage Quality System audit processes, including supplier evaluations and audits.
• Provide training to company employees in relevant areas of the Quality System.
• Manage all Quality related activities for device manufacturing ensuring effective and efficient controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
• Ensure product quality requirements are met both internally and throughout the supply chain during product manufacturing.
• Support product verification and validation, including risk management, biocompatibility testing (ISO 10993), microbiological (disinfection) validation, pre-clinical and clinical evaluations.
• Ensure activities are conducted in compliance with the regulations and standards applicable to the product.
• Strong project management skills to lead cross functional projects, ensuring on time and on budget delivery. Creative approaches to reducing project risks and shortening timelines while delivering business objectives.
• Demonstrate collaborative leadership, being able to collaborate across multiple functions, beyond Quality.
• Develop and manage a high-performance quality engineering team. Create a strong team working environment with focus on compliance, product quality, and risk mitigation.
• Manage external vendors/partners as necessary to support Quality activities.
• Ensure interactions with colleagues/stakeholders fully reflects the company values:

• Bachelor’s degree in science, engineering, or related field
• Minimum of eight (8) years in a similar role in medical device quality systems or equivalent
• Deep and current understanding of FDA and ISO 13485 requirements, with the ability to interpret these requirements and implement them into a lean compliant product.
• Experience in design, verification, and process validation processes
• Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems.
• Prior experience in class III implantable devices required.
• Experience working with sub-contract manufacturers/suppliers, including integration of quality management systems.
• Medical device management experience with quantifiable record of achievement with an ability to analyse and challenge data, identify and address gaps, and generate technical reports to support submissions.
• Good problem-solving mindset
• Good leadership and project management skills with the ability and willingness to effectively build and manage a small team. Experience in people management and development.
• Strong verbal and written communication skills
• At ease in start-up environment and effectiveness to deliver in low-structured environments.