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:
Responsible for supervising the implementation and maintenance of the Quality Systems Elements, as described in the Corporate Quality Manual, at BSC Costa Rica. Also responsible for ensuring a permanent state of compliance with corporate and current applicable regulations. Responsible for driving a Culture of Compliance at BSC Costa Rica, for performing and facilitating Quality System related Training, driving the organization to be ready to host External Audits in a successful manner.
Your Responsibilities Include:
:Supervise and assure a flawless execution of the corrective and preventive action system (CAPA).
:Supervise the correct usage of investigation tools and techniques in order to obtain effective corrective and preventive actions over the issues manage in the different quality systems including eCAPA.
:Be sure of having the correct follow up of action items related to the quality system in order to facilitate the closure of CAPAs, Internal Audits and Feeder System Investigations, as required.
:Create and Maintain a Roadmap for Compliance to Corporate/Site Commitments to External bodies and driving for effective implementation at BSC Costa Rica Site.
:Drive BSC Costa Rica to build a proactive quality Culture based on Substantial Compliance by providing relevant training, coaching, driving actions and critical disseminating of information to ensure.
:Drive BSC Costa Rica to be in a state of constant readiness to have successful audits by creating the
:procedures, driving behaviors and capabilities required to host external audits.
:Support QA Director during the activities of preparation, management and hosting of External Audits.
:Develop continuous improvements initiatives of the Quality System by providing visibility and defining activities where we can anticipate changes in the regulatory landscape.
:Support the coordination and execution of the Management Review meetings and assure the proper documentation is kept, as per local/Corporate requirements. Execute responsibilities and authorities related to Management Review meetings as per current procedures. Represent site on other Boston Scientific Management Review forums, if required.
:May oversee the management of the Internal Audit Program by the Internal Quality Auditor.
:Supervise and assure a flawless execution of the Non Conforming Event and Prevention system (NCEP).
:Act as Internal Quality Auditor or Lead Auditor, as per established requirements, if required.
:Act as Independent Reviewer for significant projects or incidents that require this person and acute;s level of expertise.
:May manage the Quality Labs of Calibrations and Microbiology
:May manage the Documentation Center
:May perform as Site Head of Quality for eCAPA responsibilities (i.e CAPA Transfers )
What Were Looking For:
:Academical Degree in Licenciature Indultrial, Electronic, Biotechnology,Electromechanical Engineering or related field.
:English Level required: C1:90:94
:Desired knowledge: Knowledge in ISO 13485, FDA regulation of 21 CFR PART 82NA, Internal Quality Auditor experience.
:At least 7 years of experience in similar position.
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform
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