As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE : BSX) is to transform lives through innovative medical solutions that improve the health of patients.
If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
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. 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.
Esta es una posición nivel II Quality Engineer.
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.
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 & 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.
Númerode la requisición : 528896
Como líder en ciencia médica durante más de 40 años, estamos comprometidos a resolver los desafíos que más importan, unidos por un profundo cuidado por la vida humana.
Nuestra misión de promover la ciencia de por vida consiste en transformar vidas a través de soluciones médicas innovadoras que mejoran la vida de los pacientes, crean valor para nuestros clientes y apoyan a nuestros empleados y las comunidades en las que operamos.
Ahora más que nunca, tenemos la responsabilidad de aplicar esos valores a todo lo que hacemos, como empresa global y como ciudadano corporativo global.