Boston Scientific Sr Quality Systems Engineer Heredia 

Costa Rica, Heredia 

267697063

Costa Rica-Heredia

Hybrid Roles:

About the Role:

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/they is/are responsible for ensuring a permanent state of compliance with Corporate and current applicable regulations

Your Responsibilities Include:

Responsible for Internal audit program for the site, including other internal auditors training, schedule development and ensuring compliance and value added by the program

Support and/or supervise other Quality System department areas when it is required.

Develop continuous improvements initiatives of the Quality System of BSC Costa Rica.

Participate & support Quality System related activities for improvement projects, transfers, new processes implementations, etc.

When acting as the eCAPA Coordinator must assure a flawless execution of the non-conforming event & corrective and preventive action systems (NCEP & CAPA) providing tracking & 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.

Execute activities and responsibilities according to applicable procedures for NCEP and CAPA

Ensure that BSC Costa Rica is in compliance with Corporate and Regulatory Requirements at all times.

May act as supervisor of other Quality System Engineers

Review and update documents within their areas of responsibility in order to be in compliance with Corporate and Regulatory Requirements

Serve as independent reviewer for significant projects or incidents as applicable.

Provide training for Quality System topics as required

Develop and/or lead continuous improvements initiatives of the Quality System.

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.

Execute activities and responsibilities according to applicable procedures for Management Review Meeting

Provide required site information to other Management Review forums held at Boston Scientific Corporation and participate/present the information if required in those forums

For those individuals that supervise others, the following statements are applicable:

Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

Establishes and promotes a work environment that supports the Quality Policy and Quality System.

What We’re Looking For:

• Degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
• English Level desired: B2:(80-89%).
• Desired knowledge: Formal Training on statistical and quality techniques desirable, ASQ Certified, Knowledge of Six Sigma, or similar tools.
• At least 5 years of experience in similar position.
• Desirable Medical Industry experience.
• Please Submit CVS in English