ISO 13485 experience is required.
Provides direct and indirect supervision to subordinate managers and employees performing diverse roles within large sites. Work is guided by broad site objectives and corporate policy. Work requires developing solutions, precedents, and/or policies. Receives assignments in the form of objectives and sets goals to achieve objectives. Establishes long-term plans/objectives and recommends changes to policies. Develops department budgets and goals. This includes establishing three- to five-year plans/objectives, and developing policies for the function/unit. Accountable for projects or programs on a multi-functional, national, or regional basis. Erroneous decisions or failure to achieve goals results in critical delay in schedules and/or unit operation and may also have a company-wide affect. Provides direct supervision to others, or indirect through subordinate supervisors, and coordinates the activities of a section or department with responsibility for results in terms of costs, methods, and employees. Reviews employees’ performance and recommends employee compensation; coaches for improved performance and disciplines as necessary. Provides final approval for subordinate managers’/supervisors’ salary and performance recommendations. Builds cross-functional relationships where persuasive skills, negotiation skills, and considerable tact are required to gain support. Interacts regularly with senior management or executive levels on matters concerning several functional areas, divisions and/or customers. Maintains positive relationships with key customers, suppliers, etc., who have a significant impact on the success of the organization.Performs tasks such as, but not limited to, the following: Develops comprehensive quality program for a large site or region integrating inputs from engineering, manufacturing and quality system users. Sets site wide quality strategy and acts as the focal point for continuous improvement. Provides leadership and direction towards executing qualify focused programs and initiatives. Oversees own engineering staff and black belts while also providing mentorship across engineering and manufacturing community. Provides leadership for continuous improvements and quality management programs such as black belt initiatives and other programs. Develops and maintains effective measurement reporting tools to track quality progress and corrective action programs. Ensures ongoing compliance with ISO 9001/9002, Standards Coordinating Committee (SCC) and British Approval Board -Technology (BABT) . Ensures proper Electrostatic Discharge (ESD) controls are in place. Directs staff by establishing overall direction and priorities. Provides direction, and is responsible for, new manufacturing quality systems. Provides ongoing support and maintenance for existing quality systems.Directs implementation of new, and/or improvement to existing, system(s) and processes that ensure the correct documentation/information/instructions (e.g., Operating Procedures, Quality system procedures, administration of Quality management systems, i.e. forms, logs, & records) are available for use and that changes are implemented in a timely manner. Ensures that system(s) and processes meet industry standards (e.g., ISO) and customer requirements while driving toward “world class” practices and standards.