Location: Dorado, [[state]], Puerto Rico (PR) Additional Locations: (n/a) Hiring Manager: Mirielle Marie Acevedo Segundo Recruiter: Sandra Martinez Miranda Provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventative actions. Assists engineers in developing methods and procedures to control or improve manufacturing processes. Responsibilities Assists engineering in providing manufacturing support by learning to analyze data and identify manufacturing issues and trends. May also train operators on basic processes and engineering changes, and perform operator certification on-the-job training and testing. Assists in identifying Manufacturing issues by working with Engineering to determine root cause and implement corrective and preventatative action. Learns process to disposition non-conforming material by utilizing quality tools and by developing knowledge of manufacturing practices and procedures. Helps to develop and implement process improvements by assisting Engineering in researching and validating changes in processes/equipment and test methods to improve yield and/or reduce cycle time per established procedures. Assists Engineering in supporting process development during new product introduction by providing input to traceability and inspection requirements, providing input for statistical process control criteria, developing manufacturing instructions, and creating training sheets and certifications. May also train operators on processes and engineering changes, and perform operator certification on-the-job training and testing. Assists Engineering with qualification and validation studies & reports by collecting, compiling, measuring, organizing and recording data, and by writing procedures. May keep lab notebook. Conducts audits of manufacturing and related areas to assess compliance with internal procedures; reviews finding to determine compliance risk and systems issues. Prepare and administer reports of audit findings and participate in post audit conference to discuss them. Evaluates corrective action plans for applicability and effectiveness. Evaluates corrective action plans for applicability and effectiveness. Responsible for the final Process Monitor Release for products prior to distribution. Qualifications: Bachelor's Degree in Technical or Science field preferred A Minimum 5 years of Experience in Medical Device and/or Pharmaceutical regulated industry. Product Quality related experience. Knowledge in Quality System, and project management, knowledge in Computer SAP and network desirable Able to work different shift, overtime & weekends as needed Fully Bilingual (English/Spanish) Boston Scientific (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. Boston Scientific is an Equal Opportunity Employer. Requisition ID: 447461 SDL2017
