Position Description Responsible to perform product, process and documentation audits to determine the extent of compliance and effectiveness of operations to documented policies, procedures, specifications and regulatory requirements. Also, performs inspection and tests in conformance to Drawings, Standard Inspection Procedures and other applicable specifications. Prepares required inspection reports, defect reports and other related inspection duties as required and in accordance with GMP's regulations and International Standard Position Responsibilities Accepts and rejects material according to specifications. Performs the necessary physical testing measurements and visual inspection to incoming material. Releases accepted material to stores and suspected defective material to MRB. Determines acceptability or rejection according to specifications for low inspection complexity such as: manual, labels, literature, visual inspections, sorting, chemicals, production supplies, packaging, sterile packaging and partial certified components. Performs sampling activities Documents inspection results. Prepares a Material Request Review Form for defective materials and reports any unusual conditions to supervisor. Assists and conducts audits to assure compliance. Supports special projects and investigations. Gathers information, in order to address product issues or investigate reporting information. Writes CAPA reports. Manages certain aspects of the quality system, which includes the CAPA Tracking System, training aspects and others. Assists in the development of training standards. Trains personnel and maintains training documentation for traceability and inspection purposes. Performs other position duties as assigned. 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 Some College or 12 undergraduate approved credits as equivalent Basic Qualifications Background Educational: Business Administration or related field Experience: o Intermediate Level: 3 Years with Some College or equivalent or 0 Years with Associates or equivalent Exposure to manufacturing environment Skills Interpersonal Relations Quality and Results Oriented Computer Literate Basic oral and written communication skills in Spanish and English Desired/ Preferred Qualifications Background Experience in medical device, pharmaceutical, or electronic industry Skills Problem Solving Teamwork Communications Continues Improvement Basic Mathematics 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
Ciudad: juncos
