Engineer III DQA 601658

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:

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 communication on quality initiative.

Key Responsibilities:

• Be a part of core project team and lead the quality engineering across the entire development cycle.
• Support the development of CTQs design input and output documents.
• Support the fixture qualification and test method validation.
• Support the development and implementation of design verification and validation plans with project design lead.
• Support product risk management usability reliability and design validation efforts for new product development and design change projects.
• Participate and implement tools like Design of Experiments (DOEs) FMEA sessions Risk Management and ensure compliance to CTQs and safety requirements.
• Responsible for coleading stage gate reviews and signatory on all PDP document approvals
• Manage electronic document control and version control on all project related documents.
• Ensure adherence to the quality systems and design assurance SOPs and Boston Scientifics PLCP.
• Support usability reliability testing verification and validation testing internal and local vendors.
• Provide statistical testing and reliability plans.
• Work closely with regulatory team to drive alignment of project documentation and regulatory requirements.
• Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
• Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan Risk Management Plan Hazard Analysis Use and Design FMEA Field Assessment Plan and Software Validation Plan if applic
• CoLead CAPA efforts and apply sound systematic problemsolving methodologies identifying prioritizing communicating and driving resolution of quality issues (e.g. 5 whys analysis IsIs Not analysis and Six Sigma problem solving methodologies).
• Devise and support the implementation of effective quality assurance process controls statistical analyses and metrics that assure products meet or exceed internal quality as well as statutory requirements.
• Participate in ISO13485 site certification for the R&D center.

Requirements:

• Bachelors (or higher) degree in engineering with preference mechanical engineering.
• 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 GD&T
• Well versed with statistical analytical techniques and s/w tools like MATLAB MINITAB.

Requisition ID:601658

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!