About this role : The Quality System Engineer is responsible for implementing and maintaining the Quality Systems Elements, as described in the Corporate Quality Manual, at BSC Costa Rica. Additionally, he/ she is responsible for ensuring a permanent state of compliance with Corporate and current applicable regulations
Your responsibilities will include:
:Ensure that BSC Costa Rica is in compliance with Corporate and Regulatory Requirements at all times.
: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.
:When acting as the CAPA Administrator / Coordinator:
:Assure a flawless execution of the corrective and preventive action system (CAPA) which ensures timely tracking, follow up and closure of the CAPAS in their different phases.
:Be in compliance with all procedure duties as the CAPA Coordinator for Costa Rica site.
:Be in compliance with Feeder System responsibilities as the "Miscellaneous" Feeder System owner.
:Follow up of action items related to the systems is expected in order to facilitate the closure of CAPAs and NCEPs.
:Manage the NCEP/CAPA system for Costa Rica sites.
:Execute activities and responsibilities according to applicable procedures for NCEP, CAPA, Feeder System Processes
:When acting as the NCMR/ MRB administrator : Coordinator:
:Assure a flawless execution of the NCMR system which ensures on time tracking, maintenance and closure of the NCEP/NCMRs investigations.
:Be in compliance with all procedure duties as the NCMR and MRB administrator for Costa Rica site.
:Assure compliance with Feeder System responsibilities as the NCMR Feeder System owner.
:Follow up of action items related to the systems is expected in order to facilitate the closure of NCEPs/NCMR .
:Manage the NCEP/NCMR System for Costa Rica site.
:Execute activities and responsibilities according to applicable procedures for non conforming product control and rework.
:Authorities related to control of non:conforming product may include: Batch electronic hold removal after completing all requirements according to appropriate procedures.
What we are looking for:
:Engineer in Electronic, Biotechnology, Electromechanical Engineering or related field
:Problem Solving
:Highly desirable experience in ISO 13485, CMDCAS (SOR/98:282), ISO 9001 FDA Regulation of 21 CFR Part 820 (GMP's)
:ISO 9NANA1 FDA Regulation of 21 CFR Part 82NA (GMP's); Internal Quality Auditor experience
:Networking
:English level 70 :80
Boston Scientific is an equal opportunity employer
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