**Engineer II, Quality Job**:
Remote Eligible: Hybrid
Onsite Location(s):
Heredia, CR
**Additional Locations**: Costa Rica-Heredia
**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 new product development and manufacturing teams, helping to ensure delivery of highest quality new products to the customer.
**Your Responsibilities Include**:
May execute the following responsibilities:
- Participates in the transfer of new products and evaluates new equipment and processes
- Supports R&D and Process Development teams in the development of manufacturing processes and launch of new products to market
- Works with Process Development and/or Manufacturing teams to validate attribute and/or variable in-process Test Methods (ATMVs / VTMVs)
- Responsible for reviewing and developing process validation protocols and reports.
Support other functional areas during the validation activities
- Works with Research&Development to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components
- Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems.
May be responsible for learning and supporting risk analyses and FMEAs.
- Get involve in various stages of equipment, test methods 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
- 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.
- 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.
- Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
- Document investigation findings in analysis report on GCS2 (Complaint System)
- Become a trainer for the Software related with complaints handling process (GCS2), as required.
- 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, Materials, Electronic, Mechanical, Electromechanical Engineering or related Field.
- English Level desired: 80-89%.
- 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, TMVs, DOE, process capability).
- At least 2 years of experience in similar position.
- Availability to travel to sending sites to support the transfer of new products
- Or an equivalent combination of education and experience.
**Requisition ID**:534779
**Job Segment**:Chemical Research, Quality Engineer, Manufacturing Engineer, R&D Engineer, Testing, Engineering, Technology