Our client is one of the fastest growing companies in the medical devices industry worldwide, recently recognized as one of the 50 Best Companies to Watch, and they have requested us to search for a Quality Director for their currently expanding manufacturing facility in Tijuana, B.C. POSITION SUMMARY: To ensure that all departments and suppliers are adhered to the requirements of laws and regulations enforced by the US FDA. Manage and coordinate the implementation of quality system programs designed to ensure continuous production of products consistent with established standards and/or customer specifications by performing the following duties personally or through subordinate supervisors. Plan, implement and direct the quality system program of the Tijuana manufacturing facility, through failure investigation reporting, corrective action initiation and tracking, and monitoring the effectiveness of changes. KEY RESPONSIBILITIES: Administrates the Tijuana manufacturing facility quality system which is designed to meet the requirements of Drug and Device Good Manufacturing Practices applicable requirements listed in FDA QSR CFR Title 21:820 and requirements of ISO 13485 Quality System Standard, as well as all pertinent aspects of the JPAL. Assures that quality system requirements are adequately defined, developed and implemented and ultimately, quality system requirements are met prior to product release. Is authorized to hold non-conforming raw materials and components at incoming inspection. Is the Quality System Management Representative for Tijuana facility during FDA, ISO and customer assessments, as well as the scheduled management review meetings. Administrates the Tijuana facility complaints program reporting and trending activities, as well as recommending corrective action to preclude recurrence. Administrates the corrective action program, including problem identification, technical assistance, and monitoring and verification of change effectively. Assures that the appropriate quality systems and regulatory affairs resources are available for verification of quality system. Assures that appropriate quality reporting systems are implemented through the manufacturing organization to provide various departmental managers with information regarding quality system performance. Administers the review of external customer specifications and assure that those specifications are attainable, or that process improvement is warranted prior to contract agreements, or that exceptions be taken. Evaluates and disposes all specification change requests, assuring compliance to quality and regulatory requirements, as well as supporting cost-reduction efforts, without decreases in customer-recognizable quality expectations. Has the ability to supervise the performance of personnel and enhance personnel development within the Company's Quality System and regulatory affairs organization. Establishes and maintains: Device master Record (DMR); Device History Record (DHR). Establish and maintain hospital complaint files in accordance with FDA 820.198. Develops plans and strategies to ensure positive employee relations and effective communications are maintained. Directs and monitors records and documentation to ensure that adequate information is maintained for review and follow- up. Plans, promotes and organizes training activities related to the quality system. Supports all programs and initiatives related to the Ethics Code, Company's Values and Sustainability programs. Supports all company Safety, Health, Environmental, and Quality programs and initiatives. Understand and implement the Quality Policy. Completes all training requirements according to Training Matrix and Quality Management System, trainings identified in the training needs assessment, and attend all training sessions when participation is required. Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position. REQUIREMENTS: Bachelor's degree in Engineering or one of the physical sciences. Master's degree in Business Administration or one of the physical sciences is preferred. ASQ Certifications are recommended. Working knowledge of statistics is required. Computer literacy and a working knowledge of GMPs, ISO standards for quality systems and JPAL The proven capability to manage a large, diverse department and ability to handle multiple priorities at a given time. J-18808-Ljbffr
