- Develop, implement, and maintain quality systems to assure FDA and ISO compliance. - Optimize quality systems to effectively identify, measure, and reduce the cost of quality activities. - Identify, support, and manage departmental resources to achieve facility business and quality objectives. - Lead all facility audits (FDA, ISO, Corporate, Division, etc.). - Plan, establish and implement an internal audit program. - Review and approve all Engineering changes to product, processes, and materials. - Promote and support multi-discipline teamwork, i.e., activities that support business objectives and quality system enhancement. - Design reporting systems which provide visibility of key quality metrics and provide leadership in establishing, reporting, implementation, trend analysis and corrective action to improve quality metric trends (i.e., rejections, scrap, complaints, etc.). - Plan, establish, and implement a facility environmental compliance program. - Plan, establish, and implement quality control plans for products manufactured within the facility. - Plan, establish, and implement a supplier assurance program. - Responsibility for Facility Process Water System and Environmental compliance. - Identify, schedule, plan, and obtain approvals from FDA and other Regulatory agencies. - Provide technical engineering leadership to Quality Engineers. - Develop leadership characteristics in direct reports. - Provide training, development, and supervision of quality assurance personnel. - Provide high level Process Control expertise to manufacturing floor. - Serve as Management Representative with authority and responsibility for assuring an effective quality system and periodically reporting on performance to management. - Other duties as assigned.
|
