Siemens Healthineer Pvt Ltd, Bangalore invites job applications for the post of Quality Engineer for the year 2020. Interested candidate for the same can check out full details below.
- Masters degree or higher in a Life Science, Engineering, or Physical Science
- Certifications, Licenses, Registrations: Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred, Green Belt or Black Belt certification preferred
- Knowledge and Experience: Demonstrated comprehensive knowledge of field of specialization to support the successful completion of complex assignments. This includes in-depth knowledge of ISO 13485, and FDA Quality System Regulations. Typically, 8-10 years of successful experience in related field and successful demonstration of Key Responsibilities.
- Direction of Others: This is an individual contributor role. Provides specialized direction to professional counterparts on teams. Leadership qualities and role model qualities demonstrated.
This position is responsible to provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes. As a Subject Matter Expert (SME), the individual must be able to lead improvement projects and training on any of the elements within Design Controls.
- Leads effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
- Serves as Subject Matter Expert for application of Design Controls in accordance to regulatory expectations
- Drives and Provides guidance, recommendations, and expectations related to Design Control, Risk Management, Quality Engineering (e.g., Quality System Regulation, EU IVDD, ISO standards, etc.)
- Ensure the comprehensive completion of Design Verification, and Design Validation activities for products
- Ensure the development and validation of appropriate test methods for product performance
- Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action
- Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results.