Quality Systems Engineer Ii

hace 5 días

Provincia de Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

**Work mode**:Onsite**Onsite Location(s)**:Cartago, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**
- At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity and inclusion excellence. Also, we have a Gender Equality Policy to support our commitment.- Hybrid Roles:
- Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.**Background on Boston Scientific Cartago**:

- This role will be one of the first positions hired to support a green field / start up operation for the 3rd Boston Scientific site in Costa Rica. A green field start up operation for a large multinational company with strong presence on the region, represents a unique opportunity for any professional on her/his career. Initial roles will be key on the development of a new team / culture and on the construction of a strategy to build a brand new and large manufacturing site that will soon support many patients around the world.**About the role**:

- Provide Quality Engineering and Quality Process support at early stages of BSC Cartago West Green Field site. Establish, develop, and maintain procedures related to different elements of the Quality Management system to meet regulatory requirements, corporate policies, internal policies, and business needs. Support product transfer activities. After transfer provide support as part of sustaining mode to manufacturing, helping to ensure delivery of highest quality product to the customer. This is a key role to prepare the manufacturing site to host successful inspections by competent authorities like FDA and external Audits by Notify Bodies (some products contain Material of Animal Origin and require Premarket Approval).**Your Responsibilities 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 & 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 & closure of the NCEP/NCMRs investigations.
- Be in compliance with all procedure duties as the NCMR & 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.
- Additional Duties:

- Ensure that BSC Costa Rica is in compliance with Corporate and Regulatory Requirements at all times.
- Review and update documents within their areas of responsibility in order to be in compliance with Corporate and Regulatory Requirements
- Support other Quality System department areas when it is required.
- Develop 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 accor

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