Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Engineer II, Quality (MES Project)
Description
The QE II will be an expert on the MES team providing knowledge of Boston Scientific Quality and Regulatory processes and business requirements to the team, as well as bringing detailed knowledge of dual site ( Fremont & San Jose) -level quality and regulatory processes. A key part of the role will involve co-ordination of common requirements of all BSC Quality and Regulatory processes across all BSC manufacturing lines and applying them in implementation of MES across the site. Assist the MES project manager in the dual site level role out.
Work with the sites and corporate quality management to address process changes and recommend optimal quality processes as a part of the eManufacturing implementation
Provide definition of the requirements for design of the system with other members of the Site Team. Ensure the system will satisfy our quality and regulatory business requirements. Work with line quality teams to resolve conflicts should they arise during development and implementation. During the initial launch deployments ensure the design process in MES matches the actual production line application and create a final configuration definition for the new application. Participate with the site team members in design, test and implementation of MES at the manufacturing locations throughout BSC. Participate in the development of standard operating procedures. Prepare documentation for inspection/testing procedures. Perform responsibilities required by the Quality System and other duties as assigned or requested.
Requirements:
3-5 Years experience with BS in Quality Engineering or related discipline. 1-3 years medical device experience required. Strong written/verbal communication skills. Demonstrated used of Quality tools/methodologies. Experience in Quality Assurance and ISO strongly desired; Experience in one or more of the following necessary: auditing, design review, sterilization, project management (product development team participation) desired. MES system knowledge an advantage. This position is defined term with an estimated duration of 2 years.
