.Why Merit?En Merit Medical, nuestra misión es desarrollar dispositivos médicos innovadores que mejoren vidas. Nuestro objetivo es integrar y desarrollar a gente que quiere construir a través de trabajo duro, en equipo y comprometido, dispositivos que salvan vidas. Juntos estamos haciendo la diferencia en la vida de pacientes de todo el mundo.ESSENTIAL FUNCTIONS PERFORMED- Ensures that quality system regulations defined in the Code of Federal Regulations - Quality System 21CFR Part 820, ISO 13485:2003 and JPAL are followed.- Provides adequate resources to meet department objectives and support operations needs.- Remove barriers which prevent objectives from being achieved and provide managerial and technical support helping others to achieve their assigned tasks.- Provides input to the department budget and manages to that budget.- Resolves problems ensuring that quality needs are bing met and manufacturing criteria are adhered to.- Handles miscellaneous problems that arise, resolves problems with product quality and quality auditing procedures and coordinates the re-work of nonconforming product.- Prepares written reports summarizing the quality status of product and systems and identifies opportunities for improvement.- Assists and coordinates the Tech Team as required.- Manages department personnel by interviewing, hiring, training, evaluating job performance, disciplining, scheduling work and other related responsibilities.- Reviews risk management files to ensure new risks or risks that have exceeded there thresholds are identified and mitigated.- Performs other related duties and tasks as required.ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS- Lifting - Not to exceed 50 lbs. - local practice may apply.- Writing- Sitting- Standing- Bending- Vision- Color perception- Depth perception- Reading- Field of vision/peripheral- Fine motor skills- Noise- Chemical vapors- Soldering fumesSUMMARY OF MINIMUM QUALIFICATIONS- Educational and or work related experience equivalent to a Bachelor's Degree in Engineering or related area, ten years of related experience, with proven management skills.- Demonstrated interpersonal skills and the ability to delegate work.- Attention to detail and good organizational skills.- Problem solving and conflict management skills.- Working knowledge of United States and international standards as applicable to the department.- Demonstrated computer skills preferably spreadsheets, word processing, database (Oracle preferred), statistical analysis and other applicable software programs.COMPETENCIES- Staff training/development- Supervisory processes- Computer skills- Budget- Scientific research- Scientific problem solving- Inventions/new designs/techniques- Work/project supervisionCOMMENTSInfectious Control Risk Category I:The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs