Role and responsibilities:

• Manage QA and RA functions covering all activities leading to commercial approval.  
• Development, implementation and maintenance of a fully compliant quality system in accordance with ISO 13485, including risk management
• Continuous improvement of the QMS to meet the requirements of all stakeholders
• Manage supplier evaluations and audits
• Ensure product quality requirements are met both internally and throughout the supply chain during product manufacturing.
• Support product verification and validation, including risk management, bio-compatibility testing (ISO 10993), microbiological (disinfection) validation and clinical evaluation
• Act as the primary point of contact with Regulatory authorities and the Notified Body to ensure the company’s activities are aligned to their requirements
• Manage all quality related activities for device manufacturing ensuring effective and efficient controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
• Develop and manage a high-performance quality engineering team.
• Manage Quality System audit processes
• Provide training to company employees in relevant areas of the quality system
• Monitor actions of global regulatory agencies to stay current with requirements and changes.

Requirements:

• Bachelor degree in science, engineering or related field
• Proven track record in a similar role with a minimum of 8 years in medical device quality systems or equivalent
• Deep and current understanding of FDA and ISO requirements, with the ability to interpret these requirements and implement them into a lean compliant product
• In depth knowledge of the EU Medical Device Directive and MEDDEV guidance documents
• 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 medical products highly preferred
• Prior experience in a medical device start up preferred.
• Experience working with sub-contract manufacturers/suppliers, including integration of quality management systems.
• Medical device CA/RA/QA/QC management experience with quantifiable record of achievement with an ability to analyze and challenge data, identify and address gaps, and generate technical reports to support submissions