Config Assurance Administrator
Medtronic - Humacao Municipio, PR

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Medtronic is an Equal Opportunity/Affirmative Action Employer
Position Description

Analyzes proposed changes of product design to determine effect on overall product and system. Coordinates modification records for management control. Establishes change orders and prepares for change authorization and documentation by company and subcontractor. Prepares reports of change effect on overall product. Reviews and analyzes released engineering change data and coordinates changes with engineering, quality, support, manufacturing, and engineering data control activities. Ensures that customer requirements are implemented and reviews change accounting activity to ensure compliance with configuration management policies.

Position Responsibilities

Drives and facilitates the timely change, approval and release of documentation according to project schedules, including the resolution of resource issues relative to the creation (e.g. word processing work).
Performs all aspects of complex engineering changes, including ECO processing, parts lists (BOM’s) changes, JD Edward input, manufacturing processes and general document verification.
Monitors configuration and documents changes management process effectiveness including the impact of changes and takes the initiative to recommend configuration and change management process improvements.
Assists in the implementation and maintenance of documentation and configuration assurance processes for the control of review, revision, distribution, production, retrieval of records associated with device master records, design history records and other quality records using document management applications such as: Documentum, Factory works,
Facilitates the timely release and changes of documentation with documentation authors and approvers (from many levels of the organization) according to project schedules.
Ensures process work flows are smooth and timely.
Assures all documentation requirements are in compliance with specifications and standards
Communicates status of documentation and its configuration to engineers, project managers, managers and senior management as requested.
Defines and maintains departmental quality record systems.
Participates in the performance and personal development of technical and clerical functions.
Prepares and conducts presentations of technical information concerning specific projects/schedules and trainings, etc.
Handles and documents CAPA’s, NCR’s and participate during Internal and External audits.
Assists the supervisor in the development and training department process, procedures and computerized databases.
Uses the DMAIC process to make recommendations of improvements to the documentation process on the site.
Identifies the Quality Records required by development and manufacturing according to internal policies and Regulatory requirements. May include the analysis and interpretation of the policies/procedures and trend data.
Participates in and leads special projects as assigned.
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).
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.
Performs other related duties as assigned.

Basic Qualifications

Educational: Science, Engineering, Business Administration or related field
Experience: 3+ Years with Bachelors, 0 with Master
Exposure to quality and manufacturing environment

Interpersonal Relations
Quality and Results Oriented
Computer Literate
Fluency speaking and writing in English and Spanish

Desired/Preferred Qualifications

Experience in medical device, pharmaceutical, or electronic industry

Problem Solving
Continues Improvement

Physical Job Requirements

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.

Mental Components: Capacity to calculate, classify, compare, coordinate, copy, edit, evaluate, interview, instruct, read, observe, organize, plan, compile, select, request and document.

Environmental: Work is performed in building’s interior with normal temperature, good illumination, air condition, clean environment and minimum risk

About this company
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Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...