Prin Quality Apps Specialist

Medtronic Inc. Juncos , PR 00777

Posted 6 days ago

Careers that Change Lives

Position Description

Develops,modifies, applies and maintains quality standards and protocol for processingmaterials into partially finished or finished materials product. Collaborates with engineering andmanufacturing functions to ensure quality standards are in place. Devises and implements methods and proceduresfor inspecting, testing and evaluating the precision and accuracy of productsand production equipment. Designs orspecifies inspection and testing mechanisms and equipment; conducts qualityassurance tests; and performs statistical analysis to assess the cost of anddetermine the responsibility for products or materials that do not meetrequired standards and specifications. Ensuresthat corrective measures meet acceptable reliability standards and thatdocumentation is compliant with requirements. May specialize in the areas of design, incoming material, productioncontrol, product evaluation and reliability, inventory control and/or researchand development as they apply to product or process quality.

Position Responsibilities

  • Designsor specifies inspection and testing mechanisms and equipment; conducts qualityassurance tests; and performs statistical analysis to assess the cost of and determinethe responsibility for, products or materials that do not meet requiredstandards and specifications.

  • Reviews and analyzes quality trends with themanufacturing team.

  • Considering the quality trends provides directions interms of setting work priorities for process enhancement.

  • Provides leadership to effective in-depth investigationsand to cross-functional, multilevel technical teams to assure causes ofnon-conformance are identified and understood, and that sound corrective/preventive actions are implemented.

  • Evaluates the implemented corrective and preventiveactions against trends and quality issues to assess effectiveness of it.

  • Leads investigation of customer complaints in alignmentwith the manufacturing engineers, and process supervisors, facilitates theimplementation process.

  • Analyzes data based on trends, recommends actions forprocess, equipment and system improvement.

  • Writes procedures, protocols and any other documentationneeded for the enhancement of systems.

  • Provides training and education to the manufacturingteam on tools for process, monitoring enhancement, procedures and equipment,analytical trouble-shooting, FMEA, statistical concept application, and QSR/ISOrequirements. Drives implementation of these tools.

  • Analyzes problems regarding inspection procedures,reaches decisions and recommends possible solutions and improvements toimplement corrective and preventive actions.

  • Initiates, reports, and recommends special studies andqualification of new products or processes to evaluate quality and reliability.

  • Analyzes and submits recommendations for facilities,environmental areas, such as particulates, humidity, calibrations, and othermonitoring.

  • Drives SPC or preventive action methods.

  • Reviews and approves qualification / validation reports,ECO's/CA's, process changes, quality records or manufacturing documentation.

  • Implements quality system improvements.

  • Conducts and assists in regulatory inspections, such as(TV, FDA, others), as well as internal audits.

  • Integrates Quality Systems Regulations into New Product& Technology Development.

Performs other position duties asassigned.

Quality Responsibilities

  • Reportsany observed or informed process and/or product non-conformities to the

Supervisor.

  • Findsresolution of Quality Situations at the area of responsibility.

  • Reportsany complaint regarding a Medtronic product to the Supervisor.

Complies with all the requirements in theoperational procedures at the area of responsibility in order to meet therequirements of all applicable Quality System regulations (e.g.: FDA Part 820Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR's).

EHS Responsibilities

  • Acknowledgeand maintain commitment with the EHS Policy.

  • Participatein the development of EHS improvement projects.

  • Participateactively in the EHS programs to achieve the objectives and targets defined forthe area.

Engineers in Projects: (if apply)

  • Ensurethat the EHS considerations, legal and corporate requirements and efficiencyindicators are included in new project design and project evaluation in orderto maximize the cost/benefit ratio and minimize the EHS impacts and risks.

  • Ensurethat EHS performance indicators are included in the selection process ofcontractors.

  • Evaluateand re-evaluate periodically the EHS performance of contractors andsub-contractors.

  • Supervisethat contractors perform their job in accordance to the EHS requirements inorder to reduce, minimize or prevent EHS impacts and risks.

Maintaincurrent knowledge of the potential EHS aspects and risks of new projects.

Minimum Education

BachelorDegree

Basic Qualifications

Background

  • Educational:Applied or Natural Science, Engineering or Science of Engineering or fieldrelated to previously mentioned background.

  • Experience:

o PrincipalLevel: 7+ Years with Diploma/ Degree or 5+ Years with Advanced Diploma/ Degree

o Timeon Engineering Internship accounts as is.

  • Exposureto quality engineering and manufacturing environment

Skills

  • AnalyticalThinking

  • ProblemSolving

  • InterpersonalRelations

  • Qualityand Results Oriented

ComputerLiterate

Fluency speaking and writing in English and

Spanish

Desired/ Preferred Qualifications

Background

  • Experiencein medical device, pharmaceutical, or electronic industry
  • ASQCCertification

Skills

  • Teamwork

  • Communications

  • ContinuesImprovement

  • ProjectManagement

  • RootCause Analysis

Technical Writing and Composition

Working Conditions

Mental Components:

Capacityto calculate, classify, compare, coordinate, copy, edit, evaluate, interview,instruct, read, observe, organize, plan, compile, select, request and document.

Physical Components:

Light workrequiring physical effort, in addition, requires communication skills,capability to move from one place to another, visual discrimination andtolerance to the use of personal protection equipment.

Environmental

Work is performed in building's interior withnormal temperature, good illumination, air condition, clean environment andminimum risk


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VIEW JOBS 12/12/2018 12:00:00 AM 2019-03-12T00:00 Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for, products or materials that do not meet required standards and specifications. <br /> • Reviews and analyzes quality trends with the manufacturing team. <br /> • Considering the quality trends provides directions in terms of setting work priorities for process enhancement. <br /> • Provides leadership to effective in-depth investigations and to cross-functional, multilevel technical teams to assure causes of non-conformance are identified and understood, and that sound corrective/ preventive actions are implemented. <br /> • Evaluates the implemented corrective and preventive actions against trends and quality issues to assess effectiveness of it. <br /> • Leads investigation of customer complaints in alignment with the manufacturing engineers, and process supervisors, facilitates the implementation process. <br /> • Analyzes data based on trends, recommends actions for process, equipment and system improvement. <br /> • Writes procedures, protocols and any other documentation needed for the enhancement of systems. <br /> • Provides training and education to the manufacturing team on tools for process, monitoring enhancement, procedures and equipment, analytical trouble-shooting, FMEA, statistical concept application, and QSR/ISO requirements. Drives implementation of these tools. <br /> • Analyzes problems regarding inspection procedures, reaches decisions and recommends possible solutions and improvements to implement corrective and preventive actions. <br /> • Initiates, reports, and recommends special studies and qualification of new products or processes to evaluate quality and reliability. <br /> • Analyzes and submits recommendations for facilities, environmental areas, such as particulates, humidity, calibrations, and other monitoring. <br /> • Drives SPC or preventive action methods. <br /> • Reviews and approves qualification / validation reports, ECO’s/CA’s, process changes, quality records or manufacturing documentation. <br /> • Implements quality system improvements. <br /> • Conducts and assists in regulatory inspections, such as (TÜV, FDA, others), as well as internal audits. <br /> • Integrates Quality Systems Regulations into New Product & Technology Development. <br />  Performs other position duties as assigned.  ISO Group Juncos PR

Prin Quality Apps Specialist

Medtronic Inc.