Engineer III SW QA 601996

Additional Locations:IndiaHaryana Gurgaon

Diversity Innovation Caring Global Collaboration Winning Spirit High Performance

At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and highperforming employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll 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:

• Develop an indepth knowledge of BSCs 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 OffTheShelf as well as everything from equipment controllers to databasedriven solutions.
• Apply these policies and procedures to the sites software systems and computerdriven 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.
• 57 years of experience in medical device R&D quality engineering systems and / or quality engineering supporting R&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 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) isnt just business its personal. And if youre a natural problemsolver 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!