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Senior Design Quality Assurance Engineer : Integrations
Location:
Marlborough, MA
Description:
Additional Location(s): N/A Diversity : Innovation : Caring : Global Collaboration : Winning Spirit: High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high:performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing : whatever your ambitions. About the Role: At Boston Scientific, the Design Assurance Engineer Integrations is a quality engineer that directly supports medical device product development and integration from an acquired system to BSCs Quality system, including design controls. This individual will work with high:performance cross:functional development team to ensure safety, quality and compliance of acquired products while continuously improving their commercial value. Initially, this position supports the transition of the acquired devices to meet regulations and BSC requirements. This position is part of the design site for the Endoscopy division and can support activities including but not limited to New Product Development, Sustaining and Life Cycle Management and Quality Systems initiatives as they relate to design and development.Provides quality engineering support to operations, product development and sustaining projects for current products on the market.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 assigned departmental, functional, site, divisional and corporate quality goals, and priorities. Provides quality engineering support within acquired products, technical development projects, new product development projects, sustaining existing product families, or system/services support.This is a hybrid position based out of Marlborough, MA with the expectation to be in the office a minimum of two days per week. Your Responsibilities Will Include: :Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V and V, Usability Testing, SW Validation, Process Validation and Labeling).:Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode, and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA). Understand and support linkage of field data and Risk Management:Apply sound, systematic problem:solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. 5 Whys analysis, Is:Is Not analysis, DMAIC problem solving methodologies).:Provide quality guidance to assure country specific compliance.:Champion compliance to company policies, work instructions and SOPs.:Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.:Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products.:Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP's, CAPA's PIRs, Field Signals Evaluations and Field Actions.:Support internal and external regulatory audits as required.:Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. Required Qualifications: :Bachelors Degree in Mechanic
Posted:
May 8 on Tip Top Job
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Senior Design Quality Assurance Engineer : Integrations is a Quality Assurance QA Engineer Job located in Marlborough MA. Find other listings like Senior Design Quality Assurance Engineer : Integrations by searching Oodle for Quality Assurance QA Engineer Jobs.
Senior Design Quality Assurance Engineer : Integrations is a Quality Assurance QA Engineer Job located in Marlborough MA. Find other listings like Senior Design Quality Assurance Engineer : Integrations by searching Oodle for Quality Assurance QA Engineer Jobs.