Site Quality Lead

Company: Disability Solutions
Location: Irving
Posted on: April 20, 2024

Job Description:

MENTOR, a member of Johnson & Johnson's Family of Companies, is recruiting for a Site Quality Lead, to be located in Irving, Texas. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at The Site Quality Lead is responsible for the overall management and efficiency of the quality management system and provides overall direction to the quality function for Mentor Texas L.P. The Site Quality Lead plans, implements, and runs the quality management system and activities including quality engineering, quality operations and laboratories, product release, quality systems, corrective and preventive action, non-conforming system, risk management processes, document control and training systems, ensuring compliance with regulatory and company requirements. Key Responsibilities:

• Serves as the site Management Representative and the legal manufacturer Person Responsible for Regulatory Compliance (PRRC) as defined in the Quality System Regulation, ISO 13485, and EU Medical Device Regulations for the Mentor Irving TX.
• Ensuring the promotion of awareness of regulatory requirements throughout the organization. Communicating to the organization the importance of meeting customer, statutory, and regulatory requirements.
• Defining the Quality objectives and annual strategic plans, which are further developed into strategic goals and objectives. Has authority and responsibility to assure the goals supporting the objectives are attained including ensuring the availability of adequate resources in consideration of the yearly manufacture volumes and other regulatory needs. Prioritize goals to achieve deadlines and the objective.
• Supervising key quality performance measures and corrective action results. Responsible for the CAPA system and reporting on the results to management with executive responsibility; recommending and initiating corrective and/or preventive action as appropriate.
• Overall risk management planning, including ongoing review of the effectiveness of risk management activities ensuring that policies, procedures and practices are established and for analyzing, evaluating and controlling product risk throughout product realization.

Keywords: Disability Solutions, Mesquite , Site Quality Lead, Other , Irving, Texas