Sr Quality Engineer

Biotechnology and Pharmaceutical Sr Quality Engineer Job Description: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.Role Statement:A Senior Design Assurance Quality Engineer is responsible for assuring all requirements of the Product Development Process (PDP), Design Controls and External Manufacturer Production Controls are met by:a) Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Product Specification, Design Review, Design V&V, SW Validation, Test Methods, Process Validation, Labeling) whether internal, co-developed or externally manufacturedb) Leading the execution of Quality deliverables such as Risk Management, Design FMEA, Quality Plans, and Field Assessment Plansc) Providing quality and compliance input and coaching for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product marking and safety certification, customer complaints, PIR’s and CAPA’sd) Supporting Corporate Quality initiatives utilizing their PDP & Design Controls expertiseKey Responsibilities:a) Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Design FMEA, Project Quality Plan, Field Assessment Plan, Risk Management Plan, Software Validation Plan)b) Provide quality and statutory guidance as needed to assure country specific compliance to the laws and regulations of the targeted market for distributionc) Provide quality and statutory guidance to Sustaining Engineering in support of post market design changes, including assessment with respect to Design Controls and PDP scaling requirementsd) Advise the project team or sustaining engineering whenever course of actions are proposed that could jeopardize FDA QSR or ISO compliancee) Assure performance of thorough complaint investigations within the statutory and corporate time constraintsf) Provide product specific supplier and co-development quality assurance expertise during supplier audits, and through approval of supplier PDP and Design Controls deliverablesg) Measure and oversee the real-time continued quality of internal and external Component and Finished Good Suppliers h) Provide key quality tending information and data for Management Reviewi) Apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issuesj) Devise and support the implementation of effective quality assurance, process controls, statistical analyses and metrics that assure products meet or exceed internal quality as well as statutory requirementsk) Champions 100% compliance to Company Policy and SOP’sQualifications: BS/BA in Engineering and/or Science Related discipline and/or equivalent experience 3-5 years in a Quality role 5-7 years experience in Medical Device and/or equivalent field Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio) Able to communicate at all organizational levels both within BSC and with outside companies Able to work well in a team environment with peer groupJob Experience:.Expected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.