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Purpose and Passion - Comprehensive Benefits - Life:Work Integration - Community - Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work.
About the Role:
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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:
*Be in compliance with all Corporate and applicable regulations related to complaint investigation management.
*Respond to FDA requests for trending and analysis
*Coordinate Quality Engineering and In Process Quality Engineering areas engineers functions and activities.
*Supervise and provide support to the Design Quality Assurance team in activities related to PDP projects.
*Participate in validation development and execution, application of process statistic techniques, implementation of improvement projects.
*Engage in the different stages of equipment and process validation: execute and/or review and/or approve reports on I.Qs, O.Qs and P.Qs.
*Supervise the function of Quality Control and provide guidance to Quality Control personnel. Assure product test activities are executed as per appropriate procedures. Includes finished goods and sub:assemblies.
*Assist with engineering evaluations/generation and updates of procedures.
*Define gages, tools and equipment for the test methods developed.
*Manage/improve systems and procedures from the Operations Quality area.
*Perform corrective action reviews and requests in the corrective action system.
*Become a trainer for the Software related with complaints handling process (GCS2), as required.
*May eventually have personnel under his/her supervision: QA Technicians, QA Inspectors, Quality Engineers or Supervisors. Supervise, organize and plan tasks for personnel under his/her supervision (if applicable). Follow up on new personnel under his/her supervision during the first three months of employment, in order to assess on:the:job performance and have documented evidence (if applicable). Follow up on new personnel under his/her supervision, in order to assess on:the:job performance (if applicable).
*His/her authorities regarding non:conforming material control and reworks may include (as per applicable local procedures): physically and electronically retain impacted or suspected material; may participate in the MRB if required, whether as an additional member or in representation of the Quality Manager; he/she may sign as Quality Manager in the disposition of non:conforming product; and approve rework instructions/execution.
What Were Looking For:
:Licenciature: Chemical, Inductrial, Electronic, Biotechnology , Electromechanical Engineering or related field.
:English Level required: C1: 90:94
:Desired knowledge: Experience on Quality Assurance on complaint handling related duties, Experience related to the application of Quality, Systems requirements such as ISO 13485, FDA21CFR, part 82NA.
:At least 7 years of experience in similar position.
About us
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 youre looking to truly make a difference to people both around the world and around the corner, theres no better place to make it happen.
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