Human Xtensions is a rapidly growing startup, developing breakthrough technology in the field of robotic Minimally Invasive Surgery (MIS). We’re looking for an awesome QA Manager to manage our core QA team that is reshaping MIS.
Responsible for maintaining and ensuring that the Company’s Quality Management System complies with FDA, ISO 13485, MDR and international medical device regulatory requirements
- Responsible for planning, developing, and executing quality assurance policies, programs, and initiatives
- Responsible for company’s product quality and reliability to meet or exceed customer expectations
- Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.
- Develop and monitor improvement programs aiming to reduce the number of defects and improve level of quality
- Review and analyze statistical data and recommend changes or quality controls to eliminate problems
- Responsible to provide quality training and guidance for company personnel
- Responsible for writing and/or guiding employees to write company procedures.
- Maintenance of QA system.
- Periodic reports to top management about quality issues and analysis MRB, CAPA, ECOs, internal and external audits, and product and process performance.
- Participating in MRB, CAPA, ECO committees.
- Responsible for customer complaint handling
- Responsible for internal audit program
- Establishment and control of product traceability system
- Ensures quality by planning, monitoring, and appraising job results
- Promotes communication between colleagues and other departments for the benefit of information flow and to curb any problems that arise
- Act as PRRC for quality related issues
- Maintaining professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies
- Manage QA Department
- Support individual growth in the team
- Bachelor’s degree
- Minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience
- Previous experience in the medical devices or life science and QA fields managements (management of QA systems, support submission of the Technical Files and FDA submissions).
- Progressive leadership experience in medical devices as Quality Site Leader
- Outstanding organizational and leadership abilities
- Excellent interpersonal and public speaking skills
- Aptitude in decision-making and problem-solving
- Capability to work with cross-functional teams with positive “can do” attitude