Drive Quality Excellence A challenging opportunity exists to lead the development and maintenance of quality systems within a healthcare industry setting. The role requires expertise in quality processes, project management, and collaboration with cross-functional teams. This position offers a dynamic chance to support and evolve regional change control and quality management systems (QMS) processes. Ensuring compliance with ISO 13485 and GxP standards is essential. Responsibilities include managing change controls, training teams, managing QMS projects, monitoring quality metrics, and implementing automation to streamline processes. The ideal candidate will possess expertise in quality processes, project management, and the ability to work collaboratively with global teams to drive continuous improvement. Additionally, proficiency in Python, Power BI, and Power Automate is highly desirable. Key Responsibilities: - Quality Metrics and Audits - Develop and implement KPIs related to monthly audit/change control/QMS objectives - Provide mitigation, correction, and improvement plans for unaccomplished targets - Cross-Functional Collaboration - Coordinate successful project execution with cross-functional teams - Regulatory Compliance - Provide guidance on interpreting policies, regulations, and procedures to ensure compliance - Process Improvement - Support self-inspections, Change Control, internal and external audits, and resolve findings - Lead and participate in projects within Audit/Change Control/QMS processes and Automation - Maintain up-to-date documentation and align activities with QMS requirements Requirements: - Education and Experience - Bachelor's Degree in life science or related field - Three years' experience in a quality role within the healthcare industry, with a focus on ISO 13485 - Skills and Qualifications - Fluent in English - Proficiency in Python, Microsoft Platforms, and Power Bi - Lead or Internal Auditor certification in QMS (e.g., ISO 13485 or GMP) Benefits and Compensation A competitive salary and benefits package are offered to support your career and well-being. This position is eligible for a short-term incentive plan to recognize individual contributions to the organization's success. We value our employees' contributions and offer a comprehensive benefits package designed to support their physical and mental health, as well as their financial security. About Us We are a leading healthcare technology company dedicated to improving patient outcomes and enhancing the quality of life for individuals around the world. Our mission is to alleviate pain, restore health, and extend life through innovative medical solutions. We are committed to diversity and inclusion in all aspects of our business, ensuring that our workforce reflects the communities we serve. Learn more about our company values and commitment to excellence by visiting our website.