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Quality Engineer II Job

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Date: Nov 23, 2021

Location: Valencia, CA, United States, 91355

Company: Boston Scientific

Additional Locations:


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.


Quality Engineer II


About the role:
Develop, implement, maintain and improve appropriate quality system elements to ensure the high quality level of new and existing products. Works with problems of moderate scope where the analysis of a situation or data requires a review of identifiable factors.


Your responsibilities include:
⦁    Provide Quality Engineering support for sustaining activities and improvement projects for commercial products: Business Continuity, Value Improvement Projects (VIP), Non-Conformance Event Prevention (NCEP), Correction and Preventive Actions (CAPA). 
⦁    Assess product configuration, design, process, and supplier changes: Design Change Analysis (DCA), Process Change Analysis (PCA), and Supplier Change Impact Assessment (SCIA).
⦁    Assess manufacturing sites' operations to ensure adequate quality system controls and resolve quality issues. Achieved through virtual meetings, phone calls, emails, or other change request methods.
⦁    Analyze design-related complaint returns and collaborate with manufacturing sites for process-related complaint returns.
⦁    Collect, analyze and trend complaint data for other groups including upper management.
⦁    Develop testing and inspection methodologies and documentation for new and existing products.  Design and install processes, procedures, and statistical techniques.  Generate test protocols/reports and execute qualification and validation testing.  Review and approve testing and inspection activities performed by technicians and others.
⦁    Perform quality trending using the NCEP/CAPA system.  Perform failure analyses and defect investigations.  Resolve quality issues and approve material dispositions.  Perform and/or lead risk analyses and failure investigations for CAPA and/or audit findings investigations.
⦁    Create, revise, and approve departmental procedures.
⦁    Design and implement Quality System processes, procedures, and techniques such as risk assessment, root cause analysis, etc.
⦁    Design and/or implement Quality System improvements.
⦁    Interface with other engineering departments, manufacturing sites, customers, and suppliers on quality related issues in a timely manner.


What we’re looking for in you:
Basic Requirements
⦁    BS/BA Degree 
⦁    2-5 years’ experience in the medical device industry with solid understanding of QSR and MDD Quality System requirements
⦁    Excellent verbal and written communication skills
⦁    Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio)

Preferred Requirements
⦁    Degree in Engineering and/or Science related discipline 


Requisition ID: 513157


As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.


So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.


Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


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