Validation and Compliance Engineer

India

Bangalore, India

June 10, 2024

The Validation and Compliance Engineer will work within the value streams to contribute to project planning. The engineer works with the team to validate that the design meets the requirements.  Ensuring that a good statement of requirements is completed so that the requirements can be validated is essential.   A risk assessment to determine what may go wrong, and mitigation plans are in place is a key output.  Up front work to ensure designs are correct is prioritized over testing.

To be successful as a validation and compliance engineer you will have a sound technical background and be up to date with the latest regulatory developments in the industry. The ideal person for this position requires solid analytical skills alongside the ability to communicate complex concepts clearly and effectively to other employees and management.   A sound knowledge of statistical techniques, problem solving methods, and knowledge of practical quality assurance and control methods is beneficial.

In addition to annual initiatives, the key accountabilities of this position are:

Validation and Compliance

• Coordinating with departments and staff to gather and analyze data
• Develop test procedures and guidelines, conduct or facilitate tests

  analyze existing compliance procedures to identify areas needing improvement

• Implement solutions, and maintain records of procedures and test results
• Guide plant QA personnel to ensure that regulatory requirements are maintained after product launch

• Research and understand relevant product and installation regulatory standards

• Support world-wide regulatory compliance of products, including RoHS, REACH, EMC, product standards, energy efficiency requirements
• Prepare certification plans for country admissions
• Coordinate with value stream teams to assure that safety certifications are available at key milestones in the development
• Provide input to create and implement regulatory compliance plans for product development programs including determination of certification requirements
• Facilitate compliance plan reviews and safety design review meetings for products, early in the design cycle
• Work with product teams, plant QA teams, and various safety and regulatory agencies to obtain product certifications and put systems in place so QA can maintain the certification
• Prepare approval applications including documentation, physical samples, test samples
• Provide project leadership for needed updates to existing products caused by new/revised standards
• Assist Regulatory Representatives during initial inspections, product investigations, and initial certification
• Prepare Declarations of Conformance
• Stay current with applicable standards, skills, and trends in regulatory compliance.
• Determine compliance by establishing compliance test standards.
• Facilitate design validation plan development, pulling together the design, test, QA, and manufacturing teams. 
• Research and work with outside test labs when in-house tests are not available
• Facilitate and lead FMEA teams with subsequent plans to prevent and detect design and process errors
• Interpret standards requirements and design systems with product teams to ensure that designs fulfill requirements
• Facilitate and manage CAPA investigations from creation through verification of effectiveness and closure.
• Provide training in hazard/risk analysis methods and FMEA.