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Purpose and Passion - Comprehensive Benefits - Life:Work Integration - Community - Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work.
About the role
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The Quality System Engineer is responsible for implementing and maintaining the Quality Systems Elements, as described in the Global Quality Manual, at BSC Costa Rica. Additionally, he/ she is responsible for ensuring a permanent state of compliance with Corporate and current applicable regulations
Youre Responsibilities Include
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Support and/or supervise other Quality System department areas when it is required.
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Develop continuous improvements initiatives of the Quality System of BSC Costa Rica.Participate and support Quality System related activities for improvement projects, transfers, new processes implementations, etc.
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When acting as the eCAPA Coordinator must assure a flawless execution of the non conforming event and corrective and preventive action systems (NCEP and CAPA) providing tracking and follow up for timely closure of the CAPAs in their different phases and NCEPs as required as well as assuring the correct manage of the eCAPA system at the site.
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Execute activities and responsibilities according to applicable procedures for NCEP and CAPA
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Ensure that BSC Costa Rica is in compliance with Corporate and Regulatory Requirements at all times.
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May act as supervisor of other Quality System EngineersReview and update documents within their areas of responsibility in order to be in compliance with Corporate and Regulatory Requirements
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Serve as independent reviewer for significant projects or incidents as applicable.Support Quality Systems Manager creating and maintaining a roadmap for Compliance to Corporate/Site Commitments to external bodies and driving for effective implementation at BSC Costa Rica
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Provide training for Quality System topics as required
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Develop and/or lead continuous improvements initiatives of the Quality System.
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Coordinate logistics and preparation of Management Review meetings; assure proper update and closure of the action items generated during the meetings. Prepare, if required, meeting minutes and distribute as required.
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Execute activities and responsibilities according to applicable procedures for Management Review Meeting
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Provide required site information to other Management Review forums held at Boston Scientific Corporation and participate/present the information if required in those forums
What were looking for
:Bachelor:Licenciature: Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field
:Experience: 5+
:Knowledge of QSRs, Six Sigma, APQP or similar tools
:Desirable: ASQ Certified and Formal training on statistical and quality techniques
:Formal studies in process and product validation is desired as well as thorough understanding of inspection techniques and statistical methods
:English level: 80:89
About us
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Requisition ID:462379
