Quality Engineer II, (Design Assurance) Job in Marlborough 01752, Massachusetts US
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.
General Summary: Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.
Serve 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.
Provide quality engineering support within technical development concepts, new product development, operational, or system/services support.
Duties and Responsibilities (including those within the quality system): Identifies and implements effective process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Act as team member in supporting quality disciplines, decisions, and practices.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
Advise management on potential improvements or enhancement to quality systems and processes in the company.
Minimum Education & Experience: ? BS in Engineering/Technical field.
MS is preferred.
? 3-5 years of technical experienceWorking Conditions: General office environment, with occasional domestic and international travel to other BSC facilities and or/meetings and conferences.
Competency Expectations: ? Familiar with the FDA, ISO, MDD and the Boston Scientific quality requirements associated with developing products in a regulated industry.
? Some understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as ISO 13485:2003? Good communication (oral and written) and presentation skills.
? Familiar with Microsoft Office SuiteJob Experience: BS in Engineering/Technical field.
MS is preferred3-5 years of technical experienceFamiliar with the FDA, ISOMinimum Education Required: BachelorYears of Experience Required: At Least 3 YearsExpected Travel Time: None
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