**Work mode**:Hybrid**Onsite Location(s)**:Heredia, H, CR**Additional Locations**: Costa Rica-Heredia**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 compromise.- Hybrid Roles:
- Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.**About the Role**:
To provide the necessary expertise and support to the EDC on all Validation Processes. Support all hardware and software issues at the relabeling/Localization department. Support the GLS system as business process lead.
**Your Responsibilities Will Include**:
- Typical project related responsibilities will include but are not limited to the following: Equipment validation, Process validation and Software validation.
- Ability to develop, implement, and manage a validation program to current FDA and GMP requirements.
- Act as Global Labeling System Business Process Lead.
- Give timely hardware support to relabeling/Localization departments.
- Independantly perform process, software and/or equipment validation activities (IQ, OQ, PQ) and develop Master validation plans for new processes or update existing Master validation plans if required.
- Responsible for reviewing and developing process/software and equipment validation protocols and reports. Support other functional areas during the validation activities
- Assist EDC personnel in the creation of statistical sampling plans, inspection methodology and quality procedures when required.
- Define gages, tools and equipment for the test methods developed.
- Work cross-functionally with other departments to accomplish tasks.
**What we are looking for**:
- Bachelor or Licenciature degree in Chemical, Materials, Mechanical, Electromechanical, Electronic, Industrial, Biomedical, Electrical Industrial Maintenance
- English Level desired: B2+ 80-90%
- Experience: At least 3 years
- Technical Competencies: ASQ certification (desired)
- Problem Solving
- Studies in product validation and verification
- Knowledge of statistical methods
- Knowledge of QSR's
- Execution oriented
- Quality oriented
- Communication
- Innovation
- Or an equivalent combination of education and experience
- Please submit Resume in English
**Requisition ID**:583333- **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.**Job Segment**:R&D Engineer, Chemical Research, R&D, Biomedical Engineering, Testing, Engineering, Research, Technology
