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Assoc Quality Systems Spec

Assoc Quality Systems Spec
Empresa:

Medtronic Inc.


Lugar:

Juncos

Detalles de la oferta

Position Description Responsible for development, implementation and maintenance of quality assurance systems, programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines. Position Responsibilities Maintains accurate training records including enrollments, creating offerings; attach content, version courses, manager waitlists, assisting with data cleanup (as directed). Support Site in their use of the corporate wide leaning management system (LMS) that is used to schedule courses, manage required training through certifications and monitor and report successful completion of training. Coordinates training logistics including scheduling instructors, rooms, etc. and printing rosters and sign in sheets. Maintains course materials and audit course materials as directed. Provides standard reporting for business. Provides technical support and respond to end user inquiries. Look for trends and seek resolution for root cause of common issues. Exhibits outstanding customer service skills. Supports projects by entering historical data and ensuring data accuracy and completion. Provides professional written and oral communication related to LMS responsibilities. Develops and implements training procedures for the certification and development of personnel. Prepares implements and administers compliance-training plans for personnel to assure compliance with procedures and regulatory requirements. Conducts training needs assessments required for compliance program and training activities. Develops and proposes compliance-training solutions to business problems. Prepares and administers on-the-job training plan to assure personnel compliance. Prepares and administers technical training curriculum to assure they are adequate and up-to-date with process and technology changes. Coordinates with the Engineering Team to assure product and technology transfers contain required training material. Facilitate process development and improvement activities. Evaluates external training provider proposals and makes recommendations to management as required for the compliance training activities. Interfaces with all internal and external auditors on matters related to compliance training and certification program. Configure and maintain the system for all site and group level documents, act as first level support for business users and define and build standard reports. Performs other related duties as required. Quality Responsibilities Reports any observed or informed process and/or product non-conformities to the Supervisor for action and resolution. Reports any complaint regarding a Medtronic product to the Supervisor. Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System Regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR's). EHS Responsibilities Acknowledge and maintain commitment with the EHS Policy. Participate in the development of EHS improvement projects. Participate actively in the EHS programs to achieve the objectives and targets defined for the area. Minimum Education Bachelor Degree Basic Qualifications Background Educational: Business Administration, Science or related field Experience: o Associate or Level 1: 0 Years with Diploma/ Degree Exposure to quality and manufacturing environment. Skills Interpersonal Relations Quality and Results Oriented Computer Literate Fluency speaking and writing in English and Spanish. Internal/External Inspections Client service orientation emphasizing quality work and attention to detail Desired/Preferred Qualifications Background Experience in medical device, pharmaceutical, or electronic industry Experience working with large global systems. Strong computer skills including proficiency in Word, Excel, and Access. Experience working with quality systems and compliance in regulated industry. Excellent written and oral communications. Skills Problem Solving Teamwork Communications Continues Improvement Analytical and collaborative problem-solving skills, Root Cause Analysis Technical Writing and Composition Technical Training Method Design Train the Trainer skills (Ability to Train others) Experience working with the LMS systems. Flexible and able to learn new systems Results-orientation with demonstrated a sense of urgency Working Conditions Mental Components: Capacity to calculate, classify, compare, coordinate, copy, edit, evaluate, interview, instruct, read, observe, organize, plan, compile, select, request and document. Physical Components: Light work requiring physical effort, in addition, requires communication skills, capability to move from one place to another, visual discrimination and tolerance to the use of personal protection equipment. Environmental Work is performed in building's interior with normal temperature, good illumination, air condition, clean environment and minimum risk SDL2017


Fuente: Adzuna_Ppc

Requisitos


Conocimientos:
Assoc Quality Systems Spec
Empresa:

Medtronic Inc.


Lugar:

Juncos

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