Additional Locations:India:Haryana, Gurgaon 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. Purpose Statement: Provide Software Quality Assurance support, to corporate software policies and regulations, at the Penangsite. Provides support on software validation requirements to project teams that are implementing software systems and provides an independent review to teams. Key Responsibilities: stylemargin:bottom:13.0px: : Develop an in:depth knowledge of BSC's policies and procedures, especially those that apply to BSCs software. Understand and be able to explain how these policies achieve compliance with appropriate regulations and standards. : Be able to interpret policies and regulations in support of a wide variety of software such as Custom, Off:The:Shelf, as well as everything from equipment controllers to database:driven solutions. : Apply these policies and procedures to the site's software systems and computer:driven equipment. : Be able to explain software validation deliverables to business owners of the applications. : Ability to perform risk analysis on multiple systems. : Create validation documentation for a wide range of software applications including equipment software. : Provide guidance and direction on the acceptability of Software Quality deliverables, based on requirements and templates given. Requirements: : Bachelors (or higher) degree in engineering with preference Computer Science. : 5:7+ years of experience in medical device R and D quality engineering, systems and / or quality engineering supporting R and D projects, design assurance and documentation. : Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation. : Sound understanding of medical device regulatory requirements for Class II and III medical devices. : Project planning : resourcing, timelines, quality and budgets. : Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). : Preference for candidates with CQE certification or similar training and experience : Proficient in project management tools like MS project. : Experience in ISO 62304 Requisition ID:601996 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 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 and look forward to connecting with you