Quality Applications Spec
Medtronic - Villalba Municipio, PR

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Medtronic is an Equal Opportunity/Affirmative Action Employer
Position Description

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Position Responsibilities

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.
Reviews and analyzes quality trends with the manufacturing team.
Considering the quality trends provides directions in terms of setting work priorities for process enhancement.
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.
Evaluates the implemented corrective and preventive actions against trends and quality issues to assess effectiveness of it.
Leads investigation of customer complaints in alignment with the manufacturing engineers, and process supervisors, facilitates the implementation process.
Analyzes data based on trends, recommends actions for process, equipment and system improvement.
Writes procedures, protocols and any other documentation needed for the enhancement of systems.
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.
Analyzes problems regarding inspection procedures, reaches decisions and recommends possible solutions and improvements to implement corrective and preventive actions.
Initiates, reports, and recommends special studies and qualification of new products or processes to evaluate quality and reliability.
Analyzes and submits recommendations for facilities, environmental areas, such as particulates, humidity, calibrations, and other monitoring.
Drives SPC or preventive action methods.
Reviews and approves qualification / validation reports, ECO’s, process changes, quality records or manufacturing documentation.
Implements quality system improvements.
Conducts and assists in regulatory inspections, such as (TÜV, FDA, others), as well as internal audits.
Integrates Quality Systems Regulations into New Product & Technology Development.
Performs other position duties as assigned.

Quality Responsibilities
Reports any observed or informed process and/or product non-conformities to the Supervisor.
Finds resolution of Quality Situations at the area of responsibility.
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.

Engineers in Projects:
Ensure that the EHS considerations, legal and corporate requirements and efficiency indicators are included in new project design and project evaluation in order to
maximize the cost/benefit ratio and minimize the EHS impacts and risks.
Ensure that EHS performance indicators are included in the selection process of contractors.
Evaluate and re-evaluate periodically the EHS performance of contractors and sub-contractors.
Supervise that contractors perform their job in accordance to the EHS requirements in order to reduce, minimize or prevent EHS impacts and risks.
Maintain current knowledge of the potential EHS aspects and risks of new projects.
Basic Qualifications

Background
Educational: Engineering or Science of Engineering (except civil) or field related to previously mentioned background.
Experience: 3+ years with Bachelor or 0 Years with Master.
Time on Engineering Internship accounts as is.
Exposure to quality engineering and manufacturing environment

Skills
Analytical Thinking
Problem Solving
Interpersonal Relations
Quality and Results Oriented
Computer Literate
Fluency speaking and writing in English and Spanish
Desired/Preferred Qualifications

Background
Experience in medical device, pharmaceutical, or electronic industry
ASQC Certification

Skills
Teamwork
Communications
Continues Improvement
Project Management
Root Cause Analysis
Technical Writing and Composition
Physical Job Requirements

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

Medtronic - 19 months ago - save job - block
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...