**Engineer II, Quality Sys**:
- Remote Eligible: Onsite- Onsite Location(s): Cartago, CR**Additional Locations**: N/A
**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance**
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
With access to the latest tools, information and training, we'll help you in advancing your skills and career.
Here, you'll be supported in progressing - whatever your ambitions.
**About the 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 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 according to applicable procedures for Management Review Meeting
- Provide required site information/metrics to other Management Review forums held at Boston Scientific Corporation and participate/present the information if required in those forums
- May supervise Compliance Technician
- May lead audit readiness activities
- 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**:
- Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Field.
- English Level desired: B2:(70-79%).
- Desired knowledge: ASQ certification (CQE, SSGB) desired, Formal studies in process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods, Scientific tools (e.g.
Gage R&R, DOE, process capability.
- At least 2 years of experience in similar position.
- Or an equivalent combination of education and experience.
**Requisition ID**:546640
**Job Segment**:Compliance, Quality Engineer, CAPA, Systems Engineer, Legal, Engineering, Management, Quality