Overview
job description
general objective:
lead, direct and control the day-to-day activity (staffing and operations) of the plant. Manages an ethylene oxide (eo) sterilizing facility as a profit center. Ensures process and material flow is efficient and in accordance with quality control regulations, maximizing capacity utilization. Maintains proper systems and resources to meet processing schedules on time and ensures operation is in compliance with sops, cgmps, 21 cfr part 820, iso 11135, iso 13485 and safety procedures, promoting safety for all operators and the team.
responsibilities
* establishes an organizational structure by assigning responsibilities, delegating authority and selecting, orienting and training direct reports.
* leads facility organizational staff by coaching, counseling, motivating and disciplining as needed; plans, monitors and appraises job results; directs and maintains activities designed to achieve and maintain high employee morale; fosters intra- and inter-department cooperation.
* achieves financial objectives by preparing operating budget, scheduling expenditures, analyzing variances, compiling and studying costs and initiating corrective actions; requesting assistance from internal financial support as needed.
* ensure a safe, clean, and secure working environment by establishing and enforcing procedures, rules and regulations; initiating fixed capital requests; monitoring all production related safety and security systems and procedures; chairs plant safety meetings that evaluate plant machinery, equipment and working conditions.
* meets processing requirements by managing production staff in the most effective manner; monitors predetermined preventive maintenance measures designed to minimize equipment-related downtime; ensures development of adequate plans for cobalt and/or ethylene oxide requirements in the most economical manner.
* ensures compliance with corporate quality procedures by initiating and monitoring related training programs.
* ensures compliance with all pertinent corporate, federal, state and local regulations and licensing requirements by keeping abreast of current and developing requirements; instituting and monitoring internal compliance programs and procedures; ensures that plant tours for external regulators are properly conducted.
* minimizes and resolves internal complaints and grievances with the assistance of the vp of operations and liaison with human resources, if appropriate.
* provides protection to employees by promoting personal protection and issuing monitoring devices in hazard areas as required by safety rules.
* directs and administers current and new business activities by developing plans and strategies to meet customer requirements and maximize profit; provides current or prospective customers tours of the facility; leads internal, regulatory or customer audits.
* meets customer requirements by managing plant operations according to established company policy; directs and coordinates all activities within the plant and coordinates requirements with the vice president of plant.
* monitors implementation of plans and strategies by collecting, analyzing and preparing reports for review by appropriate company management.
* minimizes and resolves external business related complaints by maintaining liaison with divisional quality staff and facility staff to investigate and resolve customer issues.
* promotes and protects the company reputation by participating in and representing the company in local community activities.
* strives for continuous improvement by analyzing new or alternative ways to improve operations; incorporates staff suggestions into analysis by responding to audit activities constructively and using findings to improve operations where possible.
* contributes in a team effort by performing according to the guidelines outlined in the medline code of business conduct, the gmp and other directives; supporting the directives and decisions of higher-level management and accomplishing other duties as assigned.
* through review of all reporting and transactional procedures, ensures the integrity of financial reporting and transactional procedures.
* communicates in an effective manner by utilizing accepted business practices in a courteous and professional manner to provide timely and accurate responses and service-oriented offers of assistance.
* protects company confidential information by properly storing, retrieving and distributing such information only to those authorized.
communications
* maintain effective communication with all departments.
* communicate orally and in writing.
perfil profesional
* a minimum of five (10) years of general or operational management experience or 3 years of sterilization operations management with iso and/or gmp exposure and a customer service focus.
* experience in pharmaceutical or medical device sterilization preferred, or 5 years of management experience in quality control regulations in aerospace or other critical sectors.
* experience in microsoft word, excel, and powerpoint required. Lean six sigma black belt or lean manufacturing certification preferred.
* office windows: word, excel, powerpoint, etc.
softskills
* ability to make decisions.
* conflict management and resolution.
* ability to work independently under general guidelines and supervision.
* effective interpersonal skills as demonstrated through prior management experience.
* ability to influence people in their opinions, attitude or judgments; to generalize, evaluate and make decisions in stressful situations.
* ability to negotiate.
* excellent organizational habits.
* management of personnel and work teams.
* self-motivation.
academic requirements
* bs degree in mechanical engineering, chemical engineering or another engineering field.
* master degree preferred.
medline industries, lp is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.
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