**Engineer I, Quality**:
- Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, 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.
**Remote Eligible**:Hybrid
**Onsite Location(s)**:
Heredia, H, CR
**About the role**:
Provide Quality Engineering support to Arden Hills and Heredia commercial and development products ensuring delivery of the highest quality result to the customer while supporting continuous improvement projects and quality initiatives.
Partner with R&D, Post Market, Manufacturing Engineers for support, and with product development teams to ensure development of robust new products.
This role will work in the following functions: design activities, risk management, post market surveillance and CAPA.
**Your responsibilities will include**:
- Perform process validation and verification activities and review related documentation.
Support other functional areas during the validation activities.
- Review and approve technical drawings, procedures, and protocols
- Participate in projects to identify root cause and implement corrective and preventive actions
- Participate in the understanding of nonconformance scope, implementing product stops, and determining release criteria.
Responsible for investigating nonconformances and writing required documentation
- Responsible for completing signal evaluations for assigned product areas
- Understanding of product quality plans, documents, and systems by reviewing product specifications, quality specifications, and working with quality systems.
May be responsible for learning risk analyses and FMEAs.
- Supporting design controls or post market surveillance integration activities for acquired entities
- Collects and analyzes process defect data for product/process improvement efforts (e.g.
nonconforming events, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development
- Provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
**Required **(EP1) **qualifications**:
- Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Field.
- English Level required: B2:(70-79%).
- 1 year or more in current position.
**Preferred qualifications**:
- Knowledge of basic Quality System and good documentation practices
- Experience in medical device industry in a Quality or R&D role
- Self-starter with the ability to identify improvement opportunities
- Comfort speaking to groups of individuals.
Presentation skills that comfortably and concisely translate performance and issues to peers.
- Proficient with Microsoft Office tools including Word, Excel, PowerPoint, Teams, and Outlook, etc
- Familiarity with product documentation, inspection and testing
- Desired knowledge: understanding of inspection techniques and statistical methods, scientific tools (e.g.
Gage R&R, DOE, process capability.
**Requisition ID**:541748
**Job Segment**:Medical Device Engineer, Quality Engineer, Manufacturing Engineer, Business Process, Engineering, Quality, Management