Posted: Tuesday, September 12, 2017 1:19 PM
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 this role:
Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
:Leads and/or participates in project teams coordinating the quality efforts of engineers, technicians and other professionals of various disciplines/departments to design, develop, and continuously improve medical device products. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project or in a total project of moderate scope.
:Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of standard materials, and complex data analysis.
:Facilitating and performing internal QA audits.
:Supporting developmental projects in the area of quality assurance.
:Participates in product development teams.
:Analyzing reports and returned products and recommend corrective action, as required.
:Performing statistical analysis to assess cost of, and determine the responsibility for products or materials that do not meet required standards and specifications;
:Participate in MRB as appropriate.
:May specialize in one of the areas of in:process inspection, design of product evaluation, and/or research and development as they apply to quality control.
:Assists in and performs GMP training.
:Participates in the development of standard operating procedures.
:Prepares documentation for inspection/testing procedures.
:Performs responsibilities required by the Quality System and other duties as assigned or requested.
:Leads in the implementation of assurances, process controls, and CAPA designed to meet or exceed internal and external requirements.
:Establish effective corrective action plans, as required.
:Identify non:conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems, as required.
:Perform vendor Q.A. facility audits and administer any resultant corrective action programs, as required.
:Provides project direction, coaching, and mentoring for engineering and technical team personnel.
:Proactively investigates, identifies, and implements best:in:class Quality Engineering practices.
:Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.
:Is an effective team member, fully motivated to achieve and demonstrate best practices in line with department objectives.
:Gives technical guidance to Quality Engineers, Associate Quality Engineers, technician and inspection staff.
:Works with EHS to identify significant environmental impacts of BSC:SH operations and to establish goals and targets around significant environmental impacts.
:Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.
:May complete Design Assurance Quality Enginee
• Location: menlo park, San Mateo
• Post ID: 79773018 sanmateo