**Engineer II, Quality Job**:
Remote Eligible: Onsite
Onsite Locations(s):
Alajuela, CR
Additional Locations: N/A
**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**:
Provide Process/Quality Engineering support to manufacturing or new product development teams, helping to ensure delivery of highest quality product or new products to the customer.
**Your Responsibilities Include**:
- May execute the following resposibilities:Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions.
May be responsible for working with process owner to bound product stops and document release criteria.
- 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.
- Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development
- Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
- Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
- Evaluates new equipment and processes and participates in the transfer of new products.
- Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document relating to validation.
- Read and interpret technical drawings, procedures, and protocols
- Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
- Document investigation findings in analysis report on GCS2
- Become a trainer for the Software related with complaints handling process (GCS2), as required.
- Work with Research and Development to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components
- Responsible for reviewing and developing process validation protocols and reports.
Support other functional areas during the validation activities
- Provide supervision, leadership, and overall direction to the Quality Release team to ensure they are identifying issues, quarantining defective product, and efficiently moving product through the release process.
Clarify priorities and remove roadblocks to maintain a high level of quality in accordance with ISO standards, cGMP's, Corporate and site level SOP's.
**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**:520347
**Job Segment**:Quality Engineer, Biotech, Medical, Manufacturing Engineer, Engineering, Quality, Healthcare, Science