At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending or innovations into new geographies and high:growth adjacency markets. In Interventional Cardiology, we design, develop and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. Medical Conditionswe provide solutions for include: Cardiovascular Disease, Coronary Artery Disease, and Acute Myocardial Infarction. We are able to provide a number of solutions to patientsthat include: Drug:Eluting Stents, Bare Metal Stents, Catheters, Balloons, Guide Wires, Coronary Atherectomy and Coronary Intravascular Ultrasound. We have robust product line and pipeline, and we will continue to make an investmentin Interventional treatments.
Boston Scientific is currently seeking an exceptional Sr Quality Engineerto join our winning team inHeredia.
Purpose
: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.
Responsibilities
: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.
:Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.
: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 and Training Materials by gaining knowledge of prevalent tools used and by reviewing and 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.
: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
Requirements:
:Degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related field.
:English Level: B2+: 80:89
:Formal training on statistical and quality techniques desirable;desirable ASQ Certified; knowledge of Six Sigma, Lean, APQP or similar tools;ASQ certification (CQE, SSGB) desired;formal studies in process and product validation is desired as well as thorough understanding of inspection techn
Salario:Competitive
